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 unchanged from the number of companies cited in the previous year.
The citations in the county include:
- You did not have a written hazard analysis.
- Your hazard analysis did not identify a hazard that requires a control.
- You did not document that you conducted an evaluation or reviewed and assessed an evaluation conducted by another entity to determine a foreign supplier's performance and the risk posed by a food.
Most of the companies cited were involved in the Devices sector.
All of the 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 |
|---|---|---|---|
| Calmare Therapeutics, Inc. | Devices | 05/22/2024 | Lack of Written MDR Procedures |
| Calmare Therapeutics, Inc. | Devices | 05/22/2024 | Management review - Lack of or inadequate procedures |
| Calmare Therapeutics, Inc. | Devices | 05/22/2024 | Quality audits - Lack of or inadequate procedures |
| Calmare Therapeutics, Inc. | Devices | 05/22/2024 | Design control - no procedures |
| Calmare Therapeutics, Inc. | Devices | 05/22/2024 | Lack of or inadequate procedures |
| Calmare Therapeutics, Inc. | Devices | 05/22/2024 | Lack of or inadequate complaint procedures |
| Charles Masson USA | Food and Cosmetics | 06/18/2024 | Hazard analysis written |
| Charles Masson USA | Food and Cosmetics | 06/18/2024 | Hazard analysis biological, chemical, physical |
| Charles Masson USA | Food and Cosmetics | 06/18/2024 | Evaluation - performance, risk |
| Charles Masson USA | Food and Cosmetics | 06/18/2024 | Evaluation, reevaluation - another entity |
| Charles Masson USA | Food and Cosmetics | 06/18/2024 | Evaluation, reevaluation - qualified individual |
| Charles Masson USA | Food and Cosmetics | 06/18/2024 | Approved supplier procedures - importer established |
| Charles Masson USA | Food and Cosmetics | 06/18/2024 | Supplier verification - establish written procedures |
| Charles Masson USA | Food and Cosmetics | 06/18/2024 | Verification activity assurance |
| Charles Masson USA | Food and Cosmetics | 06/18/2024 | Verification activity frequency |
| Charles Masson USA | Food and Cosmetics | 06/18/2024 | Verification activity before import, periodically |
| Charles Masson USA | Food and Cosmetics | 06/18/2024 | Audit - document |
| Charles Masson USA | Food and Cosmetics | 06/18/2024 | Verification activity review, assess |
| Charles Masson USA | Food and Cosmetics | 06/18/2024 | Record - translate to English |
| CooperSurgical, Inc. | Drugs | 05/21/2024 | Storage under appropriate conditions |
| Rapid Oxygen, Inc. | Devices | 04/26/2024 | Documentation - review in response to changes or deviations |
| Rapid Oxygen, Inc. | Devices | 04/26/2024 | Lack of or inadequate receiving acceptance procedures |
| Rapid Oxygen, Inc. | Devices | 04/26/2024 | Lack of or inadequate procedures |
| Rapid Oxygen, Inc. | Devices | 04/26/2024 | DHR - not or inadequately maintained |
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