FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Costa Rican OTC Drugmaker Hit for Testing, Stability Program

Sept. 20, 2019
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The FDA issued a warning letter to a Costa Rican OTC drug manufacturer for testing and other violations. and, an inadequate stability program and risks of cross-contamination netted a Costa Rican OTC drug manufacturer a warning letter from the FDA.

An inspection of the Polimeros y Servicios facility in San Jose revealed that the firm didn’t test its topical analgesic, antifungal, acne and skin protectant creams for identity and strength before releasing them for sale in the U.S.

The company said it would employ a third-party testing laboratory to satisfy the FDA’s requirements, but it didn’t provide information about the lab’s procedures and methods or a description of the test it would conduct, the agency said.

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