James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website
James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website
This is a 60% decrease from the number of companies cited in the previous quarter.
The citations in the county include:
- Your hazard analysis did not identify a hazard that required a preventive control.
- You did not implement your allergen monitoring procedures.
- Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.
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 |
|---|---|---|---|
| Alki Bakery, Inc. | Food and Cosmetics | 04/05/2024 | Hazard analysis - Identification of hazard |
| Alki Bakery, Inc. | Food and Cosmetics | 04/05/2024 | Allergen preventive controls - Implement |
| Bloodworks | Biologics | 05/03/2024 | Component identity verification |
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