Galephar Pharmaceutical Research Inc.June 1, 2021

FDA 483 - Galephar Pharmaceutical Research Inc. - June 01, 2021

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Record Details

An FDA inspection of Galephar Pharmaceutical Research Inc. in Juncos, PR, revealed significant deficiencies in their laboratory systems and quality control unit. The firm failed to adequately validate test methods for Roxybond ARIR Tablets and did not properly assess dissolution test raw data. Additionally, the quality unit did not follow its stability sampling plan and failed to investigate a process deviation.

Company: Galephar Pharmaceutical Research Inc.
Inspection Date: June 1, 2021
Product Type: Drugs
Office: Division of Human and Animal Food Operations - East IV
People: Raquel Gonzalez Rivera (Investigator )
Ariel Cruz Figueroa (Retired)

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ID · c2ebc29d-a183-42e3-84aa-6f364ae9f774