Agropharma Laboratories, Inc.

Warning LetterOpen

Mr. Jorge Gonzalez Camp President Agropharma Laboratories, Inc. Urb Industrial Salinas Carr 701 Salinas 00751 Puerto Rico tato@oleincorp.com agropharma_lab@yahoo.comFEI 3000203462Issued Mar 25, 2022Office of Pharmaceutical Quality Operations, Division II

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3000203462.

Violations4

Issue DateMar 25, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Agropharma Laboratories, Inc.
Location: Mr. Jorge Gonzalez Camp President Agropharma Laboratories, Inc. Urb Industrial Salinas Carr 701 Salinas 00751 Puerto Rico tato@oleincorp.com agropharma_lab@yahoo.com
FEI Number: 3000203462
Country: Puerto Rico
Issue Date: March 25, 2022
Issuing Office: Office of Pharmaceutical Quality Operations, Division II
Product Type: Drugs
Status: Open

Summary

Agropharma Laboratories, Inc., a drug manufacturer in Puerto Rico, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of over-the-counter antiseptics and hand sanitizers. The company's quality control unit failed to provide adequate oversight of drug manufacturing and did not ensure proper testing of incoming components for identity, purity, strength, and other quality attributes, resulting in adulterated drug products. The FDA found that despite the company's engagement of a consultant and submission of a response to inspection observations, no specific evidence or corrective actions were provided to address the identified deficiencies.

Agropharma Laboratories, Inc. FDA Warning Letter, March 25, 2022