There were seven companies in a city associated with Pima County that received FDA citations as a result of seven inspections conducted in the county in 2024, according to the U.S. Food and Drug Administration (FDA).
This is unchanged from the number of companies cited in the previous year.
Of the 25 citations issued, the most common citations were ‘The records that document the performance and results of the affirmative step you chose are not in English’ and ‘You did not develop an FSVP’.
Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company operated in the Biologics 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 and quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Amapa Import & Export | Food and Cosmetics | 02/13/2024 | Develop FSVP |
| CBR Systems, Inc. | Biologics | 01/17/2024 | Documentation/approval prior to implementation |
| CBR Systems, Inc. | Biologics | 01/17/2024 | Adequate control, proper conditions |
| CBR Systems, Inc. | Biologics | 01/17/2024 | Use prior to verification |
| CBR Systems, Inc. | Biologics | 01/17/2024 | Verification of label accuracy, legibility, integrity |
| CBR Systems, Inc. | Biologics | 01/17/2024 | Shipping conditions appropriate |
| Chief Power Chair, LLC | Devices | 07/30/2024 | Management review – Lack of or inadequate procedures |
| Chief Power Chair, LLC | Devices | 07/30/2024 | Quality audits – Lack of or inadequate procedures |
| Chief Power Chair, LLC | Devices | 07/30/2024 | Procedures not adequately established or maintained |
| Chief Power Chair, LLC | Devices | 07/30/2024 | Nonconforming product control |
| Chief Power Chair, LLC | Devices | 07/30/2024 | DMR – not or inadequately maintained |
| Chief Power Chair, LLC | Devices | 07/30/2024 | DHR – not or inadequately maintained |
| Chief Power Chair, LLC | Devices | 07/30/2024 | Complaints |
| Chief Power Chair, LLC | Devices | 07/30/2024 | Servicing – Lack of or inadequate procedures |
| Chimpa Comercializadora USA, LLC | Food and Cosmetics | 05/09/2024 | Records, English |
| Eurofins CellTx, Inc. | Biologics | 09/20/2024 | Testing, screening, donor eligibility procedures |
| Eurofins CellTx, Inc. | Biologics | 09/20/2024 | Deviations–evaluation, cause, corrective action |
| Eurofins CellTx, Inc. | Biologics | 09/20/2024 | Documentation of activities |
| Eurofins CellTx, Inc. | Biologics | 09/20/2024 | Capable of valid results |
| Eurofins CellTx, Inc. | Biologics | 09/20/2024 | In-house reagent production |
| Eurofins CellTx, Inc. | Biologics | 09/20/2024 | Accurate, indelible, legible |
| Eurofins CellTx, Inc. | Biologics | 09/20/2024 | Records maintained concurrently |
| Miramar Seafood, LLC | Food and Cosmetics | 07/17/2024 | Importer verification |
| Miramar Seafood, LLC | Food and Cosmetics | 07/17/2024 | Records, English |
| Molino La Fama, Inc. | Food and Cosmetics | 01/17/2024 | Develop FSVP |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
