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Frenda Corporation, a drug manufacturer in Puerto Rico, was cited for producing adulterated pharmaceutical products under insanitary conditions, including the presence of insects found in container closures and a consumer complaint of an insect in a hand sanitizer product. The facility failed to maintain adequate separation between drug manufacturing and industrial chemical production, lacked proper protection from the external environment, and violated Current Good Manufacturing Practice (CGMP) regulations under 21 CFR parts 210 and 211. The company's August 2022 response to the FDA's Form 483 observations was deemed inadequate because it failed to provide sufficient detail or evidence of corrective actions needed to achieve compliance.