# FDA 483 - Galephar Pharmaceutical Research Inc. - January 20, 2023

Source: https://www.keypedia.com/records/483/galephar-pharmaceutical-research-inc/31af354d-f774-40f1-96f0-5d6b7e534577

> FDA 483 for Galephar Pharmaceutical Research Inc. on January 20, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Galephar Pharmaceutical Research Inc.
- Inspection Date: 2023-01-20
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Galephar Pharmaceutical Research Inc. in Humacao, PR, was inspected by the FDA, resulting in two observations. The inspection revealed failures in thoroughly reviewing unexplained discrepancies related to drug product batch yields and inadequate equipment maintenance. These issues included a lack of a preventive maintenance plan and unreported damage to product contact parts, indicating potential concerns with quality control and manufacturing practices.

## Related Documents

- [CRL - Unknown Date](https://www.keypedia.com/records/crl/galephar-pharmaceutical-research-inc/23c59f5c-eb17-44d3-a3d9-da1897b48d9d)

## Related Officers

- [Jose F. Velez](https://www.keypedia.com/people/jose-f-velez/0d1951e8-3aa5-48ff-bc54-1fae8a7a57c9)
- [investigator](https://www.keypedia.com/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)
- [Alan A. Rivera](https://www.keypedia.com/people/alan-a-rivera/4bec02c3-c62e-4b3a-a6ab-02c3386549bf)

Company: https://www.keypedia.com/companies/galephar-pharmaceutical-research-inc/e38305f7-c401-4d03-8aa7-1f520179a4ea

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