Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
This is a 14.3% decrease from the number of companies cited in the previous year.
The citations in the county include:
- For a low-acid canned food, you did not verify and document that the food was produced according to the low-acid canned foods regulations.
- Your hazard analysis did not identify a hazard that requires a control.
- You did not document your review and assessment of a hazard analysis conducted by another entity and that a hazard analysis conducted by another entity was conducted by a qualified individual.
Most of the companies cited were involved in the Food and Cosmetics sector.
Of the companies cited, four should take voluntary actions to correct their managing operations (66.7%). Additionally, two companies had to take regulatory and/or administrative actions (33.3%).
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 |
---|---|---|---|
Atherstone Foods, Inc. | Food and Cosmetics | 02/08/2023 | Manufacturing, processing, packing, holding - Controls |
Atherstone Foods, Inc. | Food and Cosmetics | 02/08/2023 | Process preventive controls - Identify (Written) |
Atherstone Foods, Inc. | Food and Cosmetics | 02/08/2023 | Process preventive controls - Appropriate (Adequate) |
Atherstone Foods, Inc. | Food and Cosmetics | 02/08/2023 | Supply-chain program - Records |
Curtis Jacquot | Food and Cosmetics | 06/29/2023 | Records - cleaning, pest control |
Curtis Jacquot | Food and Cosmetics | 06/29/2023 | Procedures - equipment - cleaning, sanitizing |
Curtis Jacquot | Food and Cosmetics | 06/29/2023 | Specifications - component identity |
Curtis Jacquot | Food and Cosmetics | 06/29/2023 | Specifications-component purity, strength, composition |
Curtis Jacquot | Food and Cosmetics | 06/29/2023 | Specifications - contamination limits |
Curtis Jacquot | Food and Cosmetics | 06/29/2023 | Specifications - labels, packaging |
Curtis Jacquot | Food and Cosmetics | 06/29/2023 | Specifications - contamination limits |
Curtis Jacquot | Food and Cosmetics | 06/29/2023 | Specifications - identity, purity, strength, composition |
Curtis Jacquot | Food and Cosmetics | 06/29/2023 | Components packaging, labels used |
Curtis Jacquot | Food and Cosmetics | 06/29/2023 | Reserve sample - collect, hold |
Curtis Jacquot | Food and Cosmetics | 06/29/2023 | Master manufacturing record - each batch |
Curtis Jacquot | Food and Cosmetics | 06/29/2023 | Batch record - every batch |
Curtis Jacquot | Food and Cosmetics | 06/29/2023 | Batch record - follow master |
Curtis Jacquot | Food and Cosmetics | 06/29/2023 | Written procedures - holding |
Curtis Jacquot | Food and Cosmetics | 06/29/2023 | Hold - temperature, humidity, light |
Curtis Jacquot | Food and Cosmetics | 06/29/2023 | Records - returned dietary supplement: written procedures |
Curtis Jacquot | Food and Cosmetics | 06/29/2023 | Written procedures - product complaint; review, investigate |
Curtis Jacquot | Food and Cosmetics | 06/29/2023 | Quality control - ensure quality; package, labeled, master record |
Gourmet Plus, Inc. | Food and Cosmetics | 05/31/2023 | Grounds |
Gourmet Plus, Inc. | Food and Cosmetics | 05/31/2023 | Sanitation of food-contact surfaces - Frequency |
Pacific BioLabs | Drugs | 06/01/2023 | Procedures not in writing, fully followed |
Pacific BioLabs | Drugs | 06/01/2023 | Establishment of calibration procedures |
Pacific BioLabs | Drugs | 06/01/2023 | Written record of investigation incomplete |
Pacific BioLabs | Drugs | 06/01/2023 | Complete Test Data |
Pet Food Express | Veterinary | 12/19/2023 | LACF compliance |
Pet Food Express | Veterinary | 12/19/2023 | Hazard analysis biological, chemical, physical |
Pet Food Express | Veterinary | 12/19/2023 | Document review entity's hazard analysis |
Pet Food Express | Veterinary | 12/19/2023 | Evaluation - performance, risk |
Pet Food Express | Veterinary | 12/19/2023 | Approved supplier procedures - importer established |
Pet Food Express | Veterinary | 12/19/2023 | Supplier verification - establish written procedures |
The Bonami Baking Company, Inc. | Food and Cosmetics | 04/14/2023 | Sanitary operations - Plant maintenance |
The Bonami Baking Company, Inc. | Food and Cosmetics | 04/14/2023 | Process preventive controls - Implement |
The Bonami Baking Company, Inc. | Food and Cosmetics | 04/14/2023 | Sanitation preventive controls - Implement |
The Bonami Baking Company, Inc. | Food and Cosmetics | 04/14/2023 | Allergen preventive controls - Appropriate (Adequate) |
The Bonami Baking Company, Inc. | Food and Cosmetics | 04/14/2023 | Supply-chain program - Records |