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 unchanged from the number of companies cited in the previous year.
The citations in the county include:
- You did not establish component specifications for purity, strength and composition.
- You did not establish product specifications for the purity, strength and composition of the finished dietary supplement.
- Your quality control operations for returned dietary supplements did not include conducting a required material review and making a required disposition decision.
The companies cited were involved in either Food and Cosmetics or Veterinary 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.
According to its website, 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.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Eden's Answers, Inc. | Food and Cosmetics | 02/09/2024 | Specifications-component purity, strength, composition |
| Eden's Answers, Inc. | Food and Cosmetics | 02/09/2024 | Specifications - identity, purity, strength, composition |
| Eden's Answers, Inc. | Food and Cosmetics | 02/09/2024 | Quality control returned dietary supplement; material review, disposition |
| Eden's Answers, Inc. | Food and Cosmetics | 02/09/2024 | Records - material review, disposition documentation |
| Eden's Answers, Inc. | Food and Cosmetics | 02/09/2024 | Master manufacturing record - each batch |
| Holmes By Products Company, Inc. | Veterinary | 03/29/2024 | Hazard Analysis |
| Holmes By Products Company, Inc. | Veterinary | 03/29/2024 | Preventive Controls |
| Holmes By Products Company, Inc. | Veterinary | 03/29/2024 | Process Controls |
| Holmes By Products Company, Inc. | Veterinary | 03/29/2024 | Customer Disclosure |
| Holmes By Products Company, Inc. | Veterinary | 03/29/2024 | Establishment and Implementation of Monitoring Preventive Controls |
| Holmes By Products Company, Inc. | Veterinary | 03/29/2024 | Calibration |
| Holmes By Products Company, Inc. | Veterinary | 03/29/2024 | Record Review |
| Holmes By Products Company, Inc. | Veterinary | 03/29/2024 | Written Calibration Procedures |
| Holmes By Products Company, Inc. | Veterinary | 03/29/2024 | Contains cattle material prohibited in animal feed |
| Holmes By Products Company, Inc. | Veterinary | 03/29/2024 | Marking with readily detected agent |
Alerts Sign-up