DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website
DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website
This is a 50% increase over the number of companies cited in the previous quarter.
Of the 20 citations issued, the most common citation was '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 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.
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 |
| CTK Biotech, Inc. | Devices | 08/08/2024 | 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 |
| Emerge Diagnostics, Inc. | Devices | 08/08/2024 | Lack of or inadequate procedures |
| Next Orthosurgical, Inc. | Devices | 08/09/2024 | Documentation |
| Next Orthosurgical, Inc. | Devices | 08/09/2024 | DMR - not or inadequately maintained |
| Next Orthosurgical, Inc. | Devices | 08/09/2024 | Statistical techniques - Lack of or inadequate procedures |
| Strata Skin Sciences, Inc. | Devices | 08/22/2024 | Documentation |
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