Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
This is unchanged from the number of companies cited in the previous quarter.
Of the 23 citations issued, the most common citation was 'You did not conduct operations under conditions and controls necessary to minimize the potential for growth or survival of microorganisms'.
Most of the companies cited were involved in the Food and Cosmetics sector.
Of the companies cited, six should take voluntary actions to correct their managing operations. Additionally, one company had to take regulatory and/or administrative actions (16.7%).
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 |
|---|---|---|---|
| Adept Life Science, LLC | Food and Cosmetics | 01/25/2024 | Specifications - component identity |
| Adept Life Science, LLC | Food and Cosmetics | 01/25/2024 | Specifications-component purity, strength, composition |
| Adept Life Science, LLC | Food and Cosmetics | 01/25/2024 | Specifications - identity, purity, strength, composition |
| Adept Life Science, LLC | Food and Cosmetics | 01/25/2024 | Processes, specifications, written procedures |
| Adept Life Science, LLC | Food and Cosmetics | 01/25/2024 | QC operations - master manufacturing record, modifications |
| Adept Life Science, LLC | Food and Cosmetics | 01/25/2024 | Quality control operations - batch production records |
| Adept Life Science, LLC | Food and Cosmetics | 01/25/2024 | Quality control - components, identity specifications |
| Adept Life Science, LLC | Food and Cosmetics | 01/25/2024 | Master manufacturing record - each batch |
| Adept Life Science, LLC | Food and Cosmetics | 01/25/2024 | Batch record - complete |
| Azteca Bakeries, Incorporated | Food and Cosmetics | 02/07/2024 | Manufacturing, processing, packing, holding - Controls |
| Elote Blanco Mexicano, LLC | Food and Cosmetics | 01/19/2024 | Hazard analysis biological, chemical, physical |
| Elote Blanco Mexicano, LLC | Food and Cosmetics | 01/19/2024 | Evaluation - performance, risk |
| Elote Blanco Mexicano, LLC | Food and Cosmetics | 01/19/2024 | Supplier verification - establish written procedures |
| Elote Blanco Mexicano, LLC | Food and Cosmetics | 01/19/2024 | Verification activity frequency |
| Elote Blanco Mexicano, LLC | Food and Cosmetics | 01/19/2024 | Verification activity before import, periodically |
| ReConserve of Arizona | Veterinary | 02/01/2024 | Validation Requirements for Preventive Controls |
| ReConserve of Arizona | Veterinary | 02/01/2024 | Calibration |
| Sage & Sand Potato Processing Company, Inc. | Food and Cosmetics | 01/19/2024 | Grounds |
| Sage & Sand Potato Processing Company, Inc. | Food and Cosmetics | 01/19/2024 | Sanitary operations - Plant maintenance |
| Sage & Sand Potato Processing Company, Inc. | Food and Cosmetics | 01/19/2024 | Equipment and utensils - Design and maintenance |
| Sage & Sand Potato Processing Company, Inc. | Food and Cosmetics | 01/19/2024 | Manufacturing, processing, packing, holding - Controls |
| Stern Produce Company, Inc. | Food and Cosmetics | 03/01/2024 | Critical control points |
| Stern Produce Company, Inc. | Food and Cosmetics | 03/01/2024 | Monitoring - adequacy |
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