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# Significant CGMP Violations in Prime Lab LLC
- URL: https://www.fdaweb.com/significant-cgmp-violations-in-prime-lab-llc/
- Published: 2024-01-09T12:00:00.000Z
- Updated: 2026-09-14T14:19:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156102

A 7/31-8/4/2023 FDA inspection at the Prime Lab drug manufacturing facility in Ponce, Puerto Rico, found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished drugs. A 1/2 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-lab-llc-667057-01022024?ref=fdaweb.com) says the specific violations were:

- failing to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and failing to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals;
- failing to establish adequate written procedures for cleaning and maintaining equipment; and
- failing to establish an adequate quality control unit, and failing to have in writing and fully follow the responsibilities and procedures applicable to the quality control unit.

The letter acknowledges the firm’s commitment to cease production of drugs at the facility and asks it to clarify whether it intends to resume manufacturing drugs there in the future.

FDA says that based on the violations it identified, Prime should retain a qualified consultant to perform a comprehensive system audit of its entire operation for CGMP compliance, assist it in meeting CGMP requirements, and evaluate the completion and efficacy of all corrective and preventive actions before pursuing resolution of its compliance status with the agency.

The company was told to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with a schedule for completing the corrections.