Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
This is a 400% increase over the number of companies cited in the previous month.
The citations in the county include:
- Quality audits were not performed at sufficient frequency to determine whether the quality system activities and results comply with quality system procedures.
- Procedures for design transfer have not been adequately established.
- Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Most of the companies cited were involved in the Food and Cosmetics 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.
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 |
|---|---|---|---|
| CMR Naviscan Corporation | Devices | 07/18/2024 | Quality Audits - defined intervals |
| CMR Naviscan Corporation | Devices | 07/18/2024 | Design transfer - Lack of or inadequate procedures |
| CMR Naviscan Corporation | Devices | 07/18/2024 | Lack of or inadequate complaint procedures |
| California Splendor, Inc. | Food and Cosmetics | 07/11/2024 | Sanitation of food-contact surfaces - Frequency |
| Chula Seafood | Food and Cosmetics | 07/31/2024 | Critical limits |
| Chula Seafood | Food and Cosmetics | 07/31/2024 | Calibration - adequacy |
| Chula Seafood | Food and Cosmetics | 07/31/2024 | Monitoring record review adequacy |
| Doctor's Signature Sales and Marketing International Corporation | Food and Cosmetics | 07/10/2024 | Specifications - component identity |
| Doctor's Signature Sales and Marketing International Corporation | Food and Cosmetics | 07/10/2024 | Specifications-component purity, strength, composition |
| Doctor's Signature Sales and Marketing International Corporation | Food and Cosmetics | 07/10/2024 | Specifications - identity, purity, strength, composition |
| Doctor's Signature Sales and Marketing International Corporation | Food and Cosmetics | 07/10/2024 | Master manufacturing record - specifications; quality |
| Doctor's Signature Sales and Marketing International Corporation | Food and Cosmetics | 07/10/2024 | Batch record - complete |
| El Super Leon Ponchin Snacks, Inc. | Food and Cosmetics | 07/25/2024 | Sanitary operations - Plant maintenance |
| El Super Leon Ponchin Snacks, Inc. | Food and Cosmetics | 07/25/2024 | Food safety plan |
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