Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
This is an increase over the number of companies cited in the previous quarter.
Of the 16 citations issued, the most common citation was 'You did not establish an identity specification for each component'.
All of the companies cited were involved in the Food and Cosmetics sector.
All of the companies cited should take voluntary actions to correct their managing operations.
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 |
|---|---|---|---|
| General Research Laboratories, Inc. | Food and Cosmetics | 05/24/2024 | Specifications - component identity |
| General Research Laboratories, Inc. | Food and Cosmetics | 05/24/2024 | Specifications-component purity, strength, composition |
| General Research Laboratories, Inc. | Food and Cosmetics | 05/24/2024 | Specifications - contamination limits |
| General Research Laboratories, Inc. | Food and Cosmetics | 05/24/2024 | Specifications - labels, packaging |
| General Research Laboratories, Inc. | Food and Cosmetics | 05/24/2024 | Specifications - identity, purity, strength, composition |
| General Research Laboratories, Inc. | Food and Cosmetics | 05/24/2024 | Quality control - packaged, labeled |
| General Research Laboratories, Inc. | Food and Cosmetics | 05/24/2024 | Processes, specifications, written procedures |
| General Research Laboratories, Inc. | Food and Cosmetics | 05/24/2024 | Master manufacturing record - each batch |
| General Research Laboratories, Inc. | Food and Cosmetics | 05/24/2024 | Batch record - complete |
| Kanaloa Imports, Inc. | Food and Cosmetics | 04/12/2024 | HACCP plan implementation |
| Kanaloa Imports, Inc. | Food and Cosmetics | 04/12/2024 | Monitoring - adequacy |
| Kanaloa Imports, Inc. | Food and Cosmetics | 04/12/2024 | Verification procedures - none/frequency |
| Kanaloa Imports, Inc. | Food and Cosmetics | 04/12/2024 | Corrective action documentation |
| Kanaloa Imports, Inc. | Food and Cosmetics | 04/12/2024 | Sanitation monitoring |
| Natren, Inc. | Food and Cosmetics | 05/31/2024 | Specifications - component identity |
| Natren, Inc. | Food and Cosmetics | 05/31/2024 | Specifications - identity, purity, strength, composition |
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