# FDA 483 - Pharmacaribe llc - August 20, 2025

Source: https://www.keypedia.com/records/483/pharmacaribe-llc/558114e2-e48f-49ca-add6-76e1c43c052b

> FDA 483 for Pharmacaribe llc on August 20, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmacaribe llc
- Inspection Date: 2025-08-20
- Product Type: device
- Office Name: Florida District Office
- Summary: 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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Company: https://www.keypedia.com/companies/pharmacaribe-llc/f2307fc4-8f6f-47c8-8ae4-92ad991d9116

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9