Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
This is an increase over the number of companies cited in the previous month.
The citations in the county include:
- You did not calibrate instruments or controls used in manufacturing or testing a component or dietary supplement at the frequency specified in writing by the manufacturer or at routine intervals or as necessary to ensure the accuracy and precision of the instruments or controls.
- You did not make and keep records associated with your equipment and utensils operations.
- For component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary supplement are met and limits on contamination to ensure the quality of the dietary supplement.
The company cited was involved in the Food and Cosmetics sector.
The company cited should take a voluntary action to correct its 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 |
|---|---|---|---|
| Perez Lab, Inc. | Food and Cosmetics | 09/06/2024 | Instruments - calibration |
| Perez Lab, Inc. | Food and Cosmetics | 09/06/2024 | Make and keep records - equipment and utensils |
| Perez Lab, Inc. | Food and Cosmetics | 09/06/2024 | Specifications - components |
| Perez Lab, Inc. | Food and Cosmetics | 09/06/2024 | Specifications - labels, packaging |
| Perez Lab, Inc. | Food and Cosmetics | 09/06/2024 | Specifications - finished dietary supplement |
| Perez Lab, Inc. | Food and Cosmetics | 09/06/2024 | Component - verify identity, dietary ingredient |
| Perez Lab, Inc. | Food and Cosmetics | 09/06/2024 | Specifications met - verify; finished batch |
| Perez Lab, Inc. | Food and Cosmetics | 09/06/2024 | Documentation - requirements |
| Perez Lab, Inc. | Food and Cosmetics | 09/06/2024 | Master manufacturing record - prepared |
| Perez Lab, Inc. | Food and Cosmetics | 09/06/2024 | Master manufacturing record - record requirements |
| Perez Lab, Inc. | Food and Cosmetics | 09/06/2024 | Batch record - required information |
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