DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website
DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website
This is unchanged from the number of companies cited in the previous quarter.
The citations in the county include:
- Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
- 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.
- In-process materials are not tested for quality and approved or rejected by the quality control unit after storage for long periods.
The companies cited were involved in either Drugs or Food and Cosmetics sectors.
Both 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 |
|---|---|---|---|
| FABI - SAA, Inc. | Food and Cosmetics | 12/20/2024 | Develop FSVP |
| FABI - SAA, Inc. | Food and Cosmetics | 12/20/2024 | Verification activity - appropriate |
| Leading Pharma, LLC | Drugs | 10/21/2024 | Computer control of master formula records |
| Leading Pharma, LLC | Drugs | 10/21/2024 | Absence of Written Procedures |
| Leading Pharma, LLC | Drugs | 10/21/2024 | In-process materials characteristics testing |
| Leading Pharma, LLC | Drugs | 10/21/2024 | Test methods |
| Leading Pharma, LLC | Drugs | 10/21/2024 | Investigations of discrepancies, failures |
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