483
Pharmacaribe llcPharmacaribe llc – FDA 483, Aug 20, 2025
Record Details
Pharmacaribe, LLC, a specification developer in Punta Gorda, FL, was cited with six observations during an FDA inspection. The firm demonstrated significant deficiencies in its quality system, including failures in complaint handling, organizational structure, quality audits, CAPA documentation, management reviews, and Device Master Record maintenance. Several observations were repeats from a previous inspection, indicating persistent issues.
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ID · 558114e2-e48f-49ca-add6-76e1c43c052b
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