FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Puerto Rican Drugmaker Hit for Batch Records, Quality Control

Dec. 5, 2018
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The FDA cited OTC drug manufacturer Agropharma for violations at its Salinas, Puerto Rico facility, including inadequate conformance testing, batch records and quality control.

During an inspection held between Aug. 30 and Sept. 14, the agency noted — in a repeat observation — that drug products were released for distribution that didn’t undergo quality control testing in the lab to confirm their active ingredients met identity and strength specifications.

For one product, the investigators were “unable to determine quantity of the lot due to the invoice having two different lots with unspecified units.”

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