Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website
Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website
This is a 5% decrease from the number of companies cited in the previous year.
Of the 206 citations issued, the most common citation was 'You did not develop an FSVP'.
Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the the Devices sector.
Of the companies cited, 52 should take voluntary actions to correct their managing operations (91.2%). Additionally, seven companies had to take regulatory and/or administrative actions (12.3%).
The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.
The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.
Company Name | Area of Business | Inspection Date | Issue Cited |
---|---|---|---|
ACI Medical, LLC | Devices | 08/17/2023 | DMR - not or inadequately maintained |
ACI Medical, LLC | Devices | 08/17/2023 | DHR - UDI not included |
Abamex Distributors | Food and Cosmetics | 09/25/2023 | Develop FSVP |
Anesthesia Associates, Inc. | Devices | 12/18/2023 | Design history file |
Anesthesia Associates, Inc. | Devices | 12/18/2023 | Purchasing controls, Lack of or inadequate procedures |
Anesthesia Associates, Inc. | Devices | 12/18/2023 | Lack of or inadequate procedures - Acceptance activities |
Anesthesia Associates, Inc. | Devices | 12/18/2023 | Lack of or inadequate procedures |
Anesthesia Associates, Inc. | Devices | 12/18/2023 | DMR - not or inadequately maintained |
Anesthesia Associates, Inc. | Devices | 12/18/2023 | Lack of or inadequate DHR procedures |
Anesthesia Associates, Inc. | Devices | 12/18/2023 | Lack of or inadequate complaint procedures |
Arch Medical Solutions - Escondido, LLC | Devices | 04/07/2023 | Investigation of device failures |
Around the World Trading, Inc. | Food and Cosmetics | 08/03/2023 | Develop FSVP |
Baja Best Distributing, Inc. | Food and Cosmetics | 06/28/2023 | Develop FSVP |
California Bread Company | Food and Cosmetics | 11/28/2023 | Sanitary operations - Plant sanitation |
California Bread Company | Food and Cosmetics | 11/28/2023 | Equipment and utensils - Design and maintenance |
California Bread Company | Food and Cosmetics | 11/28/2023 | Hazard analysis - Identification of hazard |
California Bread Company | Food and Cosmetics | 11/28/2023 | Sanitation preventive controls - Implement |
California Bread Company | Food and Cosmetics | 11/28/2023 | Allergen preventive controls - Appropriate (Adequate) |
California Bread Company | Food and Cosmetics | 11/28/2023 | Sanitation preventive controls - Appropriate (Adequate) |
California Bread Company | Food and Cosmetics | 11/28/2023 | Supply-chain program - Records |
California Fertility Experts, Inc. | Biologics | 08/25/2023 | Manufacturer instructions not followed |
California Splendor, Inc. | Food and Cosmetics | 08/18/2023 | Sanitation preventive controls - Appropriate (Adequate) |
California Splendor, Inc. | Food and Cosmetics | 08/18/2023 | Supply-chain program - Assurance (Adequate) |
Cazares Del Golfo Produce | Food and Cosmetics | 08/23/2023 | Develop FSVP |
Coliman Produce, Inc. | Food and Cosmetics | 07/10/2023 | Develop FSVP |
Crown Jewels | Food and Cosmetics | 05/24/2023 | Verification activity before import, periodically |
Desert King International, LLC | Food and Cosmetics | 08/28/2023 | Hazard analysis biological, chemical, physical |
Desert King International, LLC | Food and Cosmetics | 08/28/2023 | Document review entity's hazard analysis |
Desert King International, LLC | Food and Cosmetics | 08/28/2023 | Evaluation - performance, risk |
Desert King International, LLC | Food and Cosmetics | 08/28/2023 | Approved supplier procedures - importer established |
Desert King International, LLC | Food and Cosmetics | 08/28/2023 | Verification activity assurance |
Desert King International, LLC | Food and Cosmetics | 08/28/2023 | Verification activity before import, periodically |
Diamond Orthotic Laboratory | Devices | 11/16/2023 | Training records |
Diamond Orthotic Laboratory | Devices | 11/16/2023 | Use and removal, Lack of or inadequate procedures |
Diamond Orthotic Laboratory | Devices | 11/16/2023 | Lack of or inadequate final acceptance procedures |
Diamond Orthotic Laboratory | Devices | 11/16/2023 | Complaints |
Donald M Brandon, M.D. | Biologics | 02/24/2023 | Case history records- inadequate or inadequate |
Dr. Joel Kaplan, Inc. | Devices | 06/30/2023 | Management review - Lack of or inadequate procedures |
Dr. Joel Kaplan, Inc. | Devices | 06/30/2023 | Quality audits - Lack of or inadequate procedures |
Dr. Joel Kaplan, Inc. | Devices | 06/30/2023 | Design history file |
Dr. Joel Kaplan, Inc. | Devices | 06/30/2023 | Purchasing controls, Lack of or inadequate procedures |
Dr. Joel Kaplan, Inc. | Devices | 06/30/2023 | Identification procedures, Lack of or inadequate procedures |
Dr. Joel Kaplan, Inc. | Devices | 06/30/2023 | Lack of or inadequate procedures - Acceptance activities |
Dr. Joel Kaplan, Inc. | Devices | 06/30/2023 | Lack of or inadequate complaint procedures |
E&H Distributors, LLC | Food and Cosmetics | 09/22/2023 | Develop FSVP |
El Super Leon Ponchin Snacks, Inc. | Food and Cosmetics | 06/15/2023 | Develop FSVP |
Epitope Diagnostics, Inc. | Devices | 04/28/2023 | Lack of Written MDR Procedures |
Epitope Diagnostics, Inc. | Devices | 04/28/2023 | Lack of or inadequate complaint procedures |
Esperanzas Tortillas | Food and Cosmetics | 12/22/2023 | Sanitary operations - Plant sanitation |
Esperanzas Tortillas | Food and Cosmetics | 12/22/2023 | Manufacturing, processing, packing, holding - Controls |
Excellentia Foods | Food and Cosmetics | 06/29/2023 | Pest control |
Gecko Labs, LLC | Devices | 12/14/2023 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
Gecko Labs, LLC | Devices | 12/14/2023 | Lack of or inadequate DHR procedures |
Gecko Labs, LLC | Devices | 12/14/2023 | Lack of or inadequate complaint procedures |
Gematria Products, Inc. | Food and Cosmetics | 11/21/2023 | Specifications - component identity |
Gematria Products, Inc. | Food and Cosmetics | 11/21/2023 | Appropriate tests, examinations; certificate of analysis |
Gematria Products, Inc. | Food and Cosmetics | 11/21/2023 | Master manufacturing record - specifications; quality |
Guillermo Osuna | Food and Cosmetics | 05/25/2023 | Develop FSVP |
Gustinos Company, LLC | Food and Cosmetics | 09/18/2023 | Develop FSVP |
HRC Fertility | Biologics | 05/24/2023 | Risk factors, clinical evidence |
Hawaiian Fresh Seafood, Inc. | Food and Cosmetics | 06/30/2023 | HACCP plan implementation |
Hawaiian Fresh Seafood, Inc. | Food and Cosmetics | 06/30/2023 | Food safety hazards |
Hawaiian Fresh Seafood, Inc. | Food and Cosmetics | 06/30/2023 | Corrective action plan |
Hawaiian Fresh Seafood, Inc. | Food and Cosmetics | 06/30/2023 | Verification procedures - adequacy |
Hawaiian Fresh Seafood, Inc. | Food and Cosmetics | 06/30/2023 | Importer verification |
Hawaiian Fresh Seafood, Inc. | Veterinary | 06/30/2023 | HACCP plan implementation |
Hawaiian Fresh Seafood, Inc. | Veterinary | 06/30/2023 | Food safety hazards |
Hawaiian Fresh Seafood, Inc. | Veterinary | 06/30/2023 | Corrective action plan |
Hawaiian Fresh Seafood, Inc. | Veterinary | 06/30/2023 | Verification procedures - adequacy |
Hawaiian Fresh Seafood, Inc. | Veterinary | 06/30/2023 | Importer verification |
Hygeia II Medical Group, Inc. | Devices | 08/02/2023 | Identification procedures, Lack of or inadequate procedures |
Hygeia II Medical Group, Inc. | Devices | 08/02/2023 | Lack of or inadequate receiving acceptance procedures |
Hygeia II Medical Group, Inc. | Devices | 08/02/2023 | Documentation |
Hygeia II Medical Group, Inc. | Devices | 08/02/2023 | Records of complaint investigation |
Ikal, LLC | Food and Cosmetics | 05/01/2023 | Develop FSVP |
International JGV, Inc. | Food and Cosmetics | 09/12/2023 | Develop FSVP |
Just About Foods, LLC | Food and Cosmetics | 05/03/2023 | Develop FSVP |
Kresco, LLC | Food and Cosmetics | 06/02/2023 | Develop FSVP |
Las Dos Californias, Inc. | Food and Cosmetics | 10/19/2023 | Develop FSVP |
Las Dos Californias, Inc. | Food and Cosmetics | 10/19/2023 | Hazard analysis biological, chemical, physical |
Las Dos Californias, Inc. | Food and Cosmetics | 10/19/2023 | Verification activity - appropriate |
Leong-Kuba Sea Products, Inc. | Food and Cosmetics | 02/07/2023 | HACCP plan implementation |
Leong-Kuba Sea Products, Inc. | Food and Cosmetics | 02/07/2023 | Signed and dated |
Maos Produce | Food and Cosmetics | 03/08/2023 | Develop FSVP |
Maos Produce | Food and Cosmetics | 10/16/2023 | Develop FSVP |
Mbgi USA, Inc. | Food and Cosmetics | 11/20/2023 | Develop FSVP |
Moriah Family Produce, LLC | Food and Cosmetics | 06/29/2023 | Pest control |
Moriah Family Produce, LLC | Food and Cosmetics | 06/29/2023 | Storage and Distribution |
Nature's Supplements, Inc. | Food and Cosmetics | 04/05/2023 | Specifications - component identity |
Nature's Supplements, Inc. | Food and Cosmetics | 04/05/2023 | Specifications-component purity, strength, composition |
Nature's Supplements, Inc. | Food and Cosmetics | 04/05/2023 | Specifications - identity, purity, strength, composition |
Nature's Supplements, Inc. | Food and Cosmetics | 04/05/2023 | Component - qualify supplier |
Nature's Supplements, Inc. | Food and Cosmetics | 04/05/2023 | Quality control - production, process control |
Nature's Supplements, Inc. | Food and Cosmetics | 04/05/2023 | Tests, examinations - scientifically valid |
Nature's Supplements, Inc. | Food and Cosmetics | 04/05/2023 | Quality control operations - specifications; components, packaging, labels |
Nutritional Supplement Manufacturers, Inc. | Food and Cosmetics | 08/03/2023 | Specifications - identity, purity, strength, composition |
Nutritional Supplement Manufacturers, Inc. | Food and Cosmetics | 08/03/2023 | Specifications met identity,purity, strength, comp,; basis |
Nutritional Supplement Manufacturers, Inc. | Food and Cosmetics | 08/03/2023 | Quality control production, process control; material review, disposition |
OPMX, LLC | Food and Cosmetics | 07/07/2023 | Written procedures - quality control operations |
OPMX, LLC | Food and Cosmetics | 07/07/2023 | Written procedures - returned dietary supplement |
OPMX, LLC | Food and Cosmetics | 07/07/2023 | Written procedures - product complaint |
OPMX, LLC | Food and Cosmetics | 07/07/2023 | Personnel - quality control operations; identified |
Opera Patisserie, Inc. | Food and Cosmetics | 09/27/2023 | Sanitary operations - Plant sanitation |
Pacira Pharmaceuticals, Inc. | Drugs | 04/19/2023 | Written calibration / inspection records not kept |
Pacira Pharmaceuticals, Inc. | Drugs | 04/19/2023 | Investigations of discrepancies, failures |
Pacira Pharmaceuticals, Inc. | Veterinary | 04/19/2023 | Written calibration / inspection records not kept |
Pacira Pharmaceuticals, Inc. | Veterinary | 04/19/2023 | Investigations of discrepancies, failures |
Provisional Health, Corp. | Food and Cosmetics | 04/03/2023 | Specifications - component identity |
Provisional Health, Corp. | Food and Cosmetics | 04/03/2023 | Specifications-component purity, strength, composition |
Provisional Health, Corp. | Food and Cosmetics | 04/03/2023 | Specifications - identity, purity, strength, composition |
Provisional Health, Corp. | Food and Cosmetics | 04/03/2023 | QC- required operations equipment, instruments, controls |
Provisional Health, Corp. | Food and Cosmetics | 04/03/2023 | Quality control - reject; specification not met |
San Diego Fertility Center, Medical Group, Inc. | Biologics | 05/26/2023 | Risk factors, clinical evidence |
San Diego Seafood, Inc. | Food and Cosmetics | 02/16/2023 | HACCP plan implementation |
San Diego Seafood, Inc. | Food and Cosmetics | 02/16/2023 | Food safety hazards |
San Diego Seafood, Inc. | Food and Cosmetics | 02/16/2023 | Records - content |
San Diego Seafood, Inc. | Food and Cosmetics | 02/16/2023 | Sanitation monitoring |
Societal Cdmo San Diego, LLC | Drugs | 01/25/2023 | Procedures not in writing, fully followed |
Societal Cdmo San Diego, LLC | Drugs | 01/25/2023 | Buildings of Suitable Size, Construction, Location |
Societal Cdmo San Diego, LLC | Drugs | 01/25/2023 | Investigations of discrepancies, failures |
Sol-ti, Inc. | Food and Cosmetics | 10/05/2023 | Specifications - component identity |
Sol-ti, Inc. | Food and Cosmetics | 10/05/2023 | Specifications - identity, purity, strength, composition |
Sol-ti, Inc. | Food and Cosmetics | 10/05/2023 | Written procedures - quality control operations |
Sol-ti, Inc. | Food and Cosmetics | 10/05/2023 | Master manufacturing record - unique formulation |
Sol-ti, Inc. | Food and Cosmetics | 10/05/2023 | Batch record - every batch |
Sol-ti, Inc. | Food and Cosmetics | 10/05/2023 | Hazard analysis - Identification of hazard |
Sol-ti, Inc. | Food and Cosmetics | 10/05/2023 | Sanitation monitoring |
Sol-ti, Inc. | Food and Cosmetics | 10/05/2023 | HACCP plan - not validated |
Sol-ti, Inc. | Veterinary | 10/05/2023 | Specifications - component identity |
Sol-ti, Inc. | Veterinary | 10/05/2023 | Specifications - identity, purity, strength, composition |
Sol-ti, Inc. | Veterinary | 10/05/2023 | Written procedures - quality control operations |
Sol-ti, Inc. | Veterinary | 10/05/2023 | Master manufacturing record - unique formulation |
Sol-ti, Inc. | Veterinary | 10/05/2023 | Batch record - every batch |
Sol-ti, Inc. | Veterinary | 10/05/2023 | Hazard analysis - Identification of hazard |
Sol-ti, Inc. | Veterinary | 10/05/2023 | Sanitation monitoring |
Sol-ti, Inc. | Veterinary | 10/05/2023 | HACCP plan - not validated |
Sol-ti, Inc. | Food and Cosmetics | 02/08/2023 | Specifications - component identity |
Sol-ti, Inc. | Food and Cosmetics | 02/08/2023 | Specifications - identity, purity, strength, composition |
Sol-ti, Inc. | Food and Cosmetics | 02/08/2023 | Written procedures - quality control operations |
Sol-ti, Inc. | Food and Cosmetics | 02/08/2023 | Master manufacturing record - unique formulation |
Sol-ti, Inc. | Food and Cosmetics | 02/08/2023 | Batch record - every batch |
Sol-ti, Inc. | Food and Cosmetics | 02/08/2023 | Hazard analysis - Identification of hazard |
Sol-ti, Inc. | Food and Cosmetics | 02/08/2023 | Sanitation monitoring |
Sol-ti, Inc. | Food and Cosmetics | 02/08/2023 | All hazards not considered |
Sol-ti, Inc. | Food and Cosmetics | 02/08/2023 | HACCP plan not implemented |
Sol-ti, Inc. | Food and Cosmetics | 02/08/2023 | HACCP plan - food hazards not listed |
Sol-ti, Inc. | Food and Cosmetics | 02/08/2023 | HACCP plan - verify procedures / frequency - none listed |
Sol-ti, Inc. | Food and Cosmetics | 02/08/2023 | Calibration, testing - no records |
Sol-ti, Inc. | Food and Cosmetics | 02/08/2023 | HACCP plan - not validated |
Sol-ti, Inc. | Veterinary | 02/08/2023 | Specifications - component identity |
Sol-ti, Inc. | Veterinary | 02/08/2023 | Specifications - identity, purity, strength, composition |
Sol-ti, Inc. | Veterinary | 02/08/2023 | Written procedures - quality control operations |
Sol-ti, Inc. | Veterinary | 02/08/2023 | Master manufacturing record - unique formulation |
Sol-ti, Inc. | Veterinary | 02/08/2023 | Batch record - every batch |
Sol-ti, Inc. | Veterinary | 02/08/2023 | Hazard analysis - Identification of hazard |
Sol-ti, Inc. | Veterinary | 02/08/2023 | Sanitation monitoring |
Sol-ti, Inc. | Veterinary | 02/08/2023 | All hazards not considered |
Sol-ti, Inc. | Veterinary | 02/08/2023 | HACCP plan not implemented |
Sol-ti, Inc. | Veterinary | 02/08/2023 | HACCP plan - food hazards not listed |
Sol-ti, Inc. | Veterinary | 02/08/2023 | HACCP plan - verify procedures / frequency - none listed |
Sol-ti, Inc. | Veterinary | 02/08/2023 | Calibration, testing - no records |
Sol-ti, Inc. | Veterinary | 02/08/2023 | HACCP plan - not validated |
Spinergy, Inc. | Devices | 08/15/2023 | Lack of Written MDR Procedures |
Spinergy, Inc. | Devices | 08/15/2023 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
Spinergy, Inc. | Devices | 08/15/2023 | Documentation |
Spinergy, Inc. | Devices | 08/15/2023 | DHR content |
Supreme Fruit Produce, Inc. | Food and Cosmetics | 02/02/2023 | Develop FSVP |
Supreme Lab Nutrition, LLC | Food and Cosmetics | 08/25/2023 | Specifications - component identity |
Supreme Lab Nutrition, LLC | Food and Cosmetics | 08/25/2023 | Specifications-component purity, strength, composition |
Supreme Lab Nutrition, LLC | Food and Cosmetics | 08/25/2023 | Specifications - labels, packaging |
Supreme Lab Nutrition, LLC | Food and Cosmetics | 08/25/2023 | Specifications - identity, purity, strength, composition |
Supreme Lab Nutrition, LLC | Food and Cosmetics | 08/25/2023 | Written procedures - components |
Supreme Lab Nutrition, LLC | Food and Cosmetics | 08/25/2023 | Packaging description, representative label |
Supreme Lab Nutrition, LLC | Food and Cosmetics | 08/25/2023 | Batch record - identifier; packaging |
Supreme Lab Nutrition, LLC | Food and Cosmetics | 08/25/2023 | Quality control - processes, specifications, written procedures |
Surgitech, Inc. | Devices | 08/10/2023 | Lack of System for Timely Submission of Reports |
Surgitech, Inc. | Devices | 08/10/2023 | Management review - defined interval, sufficient frequency |
Surgitech, Inc. | Devices | 08/10/2023 | Quality Audits - defined intervals |
Surgitech, Inc. | Devices | 08/10/2023 | Training - Lack of or inadequate procedures |
Surgitech, Inc. | Devices | 08/10/2023 | Design plans- updated |
Surgitech, Inc. | Devices | 08/10/2023 | Acceptable supplier records, inadequate records |
Surgitech, Inc. | Devices | 08/10/2023 | Equipment control activity documentation |
Surgitech, Inc. | Devices | 08/10/2023 | Lack of or inadequate procedures |
Surgitech, Inc. | Devices | 08/10/2023 | DHR - not or inadequately maintained |
Surgitech, Inc. | Devices | 08/10/2023 | Complaints |
Tandem Diabetes Care, Inc. | Devices | 03/23/2023 | Lack of or inadequate procedures |
Trade Rooster, Inc. | Food and Cosmetics | 08/31/2023 | Develop FSVP |
Trade Rooster, Inc. | Food and Cosmetics | 08/31/2023 | Supplier approval - document |
Trade Rooster, Inc. | Food and Cosmetics | 08/31/2023 | Verification activity - appropriate |
Trade Rooster, Inc. | Food and Cosmetics | 08/31/2023 | Verification activity before import, periodically |
True Function Laboratory, Inc. | Devices | 08/07/2023 | Management review - Lack of or inadequate procedures |
True Function Laboratory, Inc. | Devices | 08/07/2023 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
True Function Laboratory, Inc. | Devices | 08/07/2023 | Lack of or inadequate procedures - Acceptance activities |
True Function Laboratory, Inc. | Devices | 08/07/2023 | Nonconforming product, Lack of or inadequate procedures |
True Function Laboratory, Inc. | Devices | 08/07/2023 | Documentation |
True Function Laboratory, Inc. | Devices | 08/07/2023 | Lack of or inadequate DHR procedures |
True Function Laboratory, Inc. | Devices | 08/07/2023 | Review and evaluation for investigation |
Vidasoy | Food and Cosmetics | 03/30/2023 | Sanitary operations - Plant maintenance |
Vidasoy | Food and Cosmetics | 03/30/2023 | Pest control |
Vidasoy | Food and Cosmetics | 03/30/2023 | Manufacturing, processing, packing, holding - Controls |
Vidasoy | Food and Cosmetics | 03/30/2023 | Procedural requirements |
Vmaco, Inc. | Food and Cosmetics | 06/08/2023 | Develop FSVP |
Zuland Distributor, CORP | Food and Cosmetics | 09/28/2023 | Develop FSVP |
Zuland Distributor, CORP | Food and Cosmetics | 09/28/2023 | Verification activity - appropriate |
Zuland Distributor, CORP | Food and Cosmetics | 09/28/2023 | Verification activity before import, periodically |
Zuland Distributor, CORP | Food and Cosmetics | 09/28/2023 | Audit - food safety regulation, plan |