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.
The citations in the county were 'Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess' and 'There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed'.
The company cited should take a voluntary action to correct its 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 |
|---|---|---|---|
| Charles River Laboratories, Inc. | Drugs | 01/04/2024 | Absence of Written Procedures |
| Charles River Laboratories, Inc. | Drugs | 01/04/2024 | Investigations of discrepancies, failures |
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