North Inland News

There were 10 companies in cities associated with San Diego County that received FDA citations as a result of 10 inspections conducted in the county over the fourth quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 52.4% decrease from the number of companies cited in the previous quarter.

Of the 47 citations issued, the most common citations include:

• You did not establish an identity specification for each component.
• You did not develop an FSVP.
• Your hazard analysis did not identify a hazard that required a preventive control.

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 .

Of the companies cited, eight should take voluntary actions to correct their managing operations (80%). Additionally, two companies had to take regulatory and/or administrative actions (20%).

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
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
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
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
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
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
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
Maos Produce	Food and Cosmetics	10/16/2023	Develop FSVP
Mbgi USA, Inc.	Food and Cosmetics	11/20/2023	Develop FSVP
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