Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website
Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website
This is an increase over the number of companies cited in the previous quarter.
The citations in the county include:
- You did not establish an identity specification for each component.
- You did not establish component specifications for purity and strength.
- You did not establish product specifications for the of the finished dietary supplement.
The company cited was involved in the Food and Cosmetics sector.
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 |
|---|---|---|---|
| BodyBio, Inc. | Food and Cosmetics | 04/26/2024 | Specifications - component identity |
| BodyBio, Inc. | Food and Cosmetics | 04/26/2024 | Specifications-component purity, strength, composition |
| BodyBio, Inc. | Food and Cosmetics | 04/26/2024 | Specifications - identity, purity, strength, composition |
| BodyBio, Inc. | Food and Cosmetics | 04/26/2024 | Documentation - qualify supplier |
| BodyBio, Inc. | Food and Cosmetics | 04/26/2024 | Re-confirm certificate of analysis |
| BodyBio, Inc. | Food and Cosmetics | 04/26/2024 | Quality control operations - equipment records |
| BodyBio, Inc. | Food and Cosmetics | 04/26/2024 | Master manufacturing record - each batch |
| BodyBio, Inc. | Food and Cosmetics | 04/26/2024 | Batch record - date, time; maintenance |
| BodyBio, Inc. | Food and Cosmetics | 04/26/2024 | Batch record - yield |
| BodyBio, Inc. | Food and Cosmetics | 04/26/2024 | Examination, testing; appropriate |
| BodyBio, Inc. | Food and Cosmetics | 04/26/2024 | Manufacturing history |
| BodyBio, Inc. | Food and Cosmetics | 04/26/2024 | Clean, sanitize - filling, packaging equipment |
| BodyBio, Inc. | Food and Cosmetics | 04/26/2024 | Product complaint - quality control investigate |
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