# FDA 483 - Prime Lab LLC - August 04, 2023

Source: https://www.keypedia.com/records/483/prime-lab-llc/21c684d0-d326-4495-90b5-e2b355a4d709

> FDA 483 for Prime Lab LLC on August 04, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Prime Lab LLC
- Inspection Date: 2023-08-04
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Prime Lab LLC, a drug manufacturer in Ponce, PR, was inspected and cited for severe deficiencies across its quality system, laboratory controls, materials management, facilities, equipment, and production processes. The firm lacks fundamental procedures, documentation, and oversight for critical manufacturing operations, including quality control, product testing, stability, raw material identity, contamination prevention, equipment maintenance, and process controls. These issues indicate a pervasive failure to adhere to good manufacturing practices.

## Related Officers

- [Suzanne N. Vallez](https://www.keypedia.com/people/suzanne-n-vallez/7c16e0f4-c0b1-4f50-adfa-b1dc534694cd)

Company: https://www.keypedia.com/companies/prime-lab-llc/0027e827-3d61-4b9e-bb47-5b87e7d22282

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6