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

Source: https://www.keypedia.com/records/483/galephar-pharmaceutical-research-inc/c2ebc29d-a183-42e3-84aa-6f364ae9f774

> FDA 483 for Galephar Pharmaceutical Research Inc. on June 01, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Galephar Pharmaceutical Research Inc.
- Inspection Date: 2021-06-01
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: 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.

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Company: https://www.keypedia.com/companies/galephar-pharmaceutical-research-inc/9718f387-543c-4e81-ae61-054ddea9a225

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6