Artesanales P.R. LLCOctober 23, 2023

FDA 483 - Artesanales P.R. LLC - October 23, 2023

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Record Details

Artesanales P.R. LLC, a drug manufacturer in Bayamon, PR, was cited for significant deficiencies in its quality system and production controls. The inspection revealed a complete absence of a quality control unit, inadequate validation and stability programs, and failures in raw material identity testing. Additionally, the firm failed to investigate out-of-specification results and lacked proper documentation practices for batch records and yield calculations.

Company: Artesanales P.R. LLC
Inspection Date: October 23, 2023
Product Type: Drugs
Office: Division of Human and Animal Food Operations - East IV
Person: Angelica M. Hernandez

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ID · c688b633-7752-48db-8aac-82569a1bdb83