# FDA 483 - Galephar Pharmaceutical Research Inc. - October 18, 2024

Source: https://www.globalkeysolutions.net/records/483/galephar-pharmaceutical-research-inc/5f826b5e-84a6-4b50-9060-fc43caa37ad1

> FDA 483 for Galephar Pharmaceutical Research Inc. on October 18, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Galephar Pharmaceutical Research Inc.
- Inspection Date: 2024-10-18
- Product Type: drugs
- Office Name: San Juan District Office
- Summary: Galephar Pharmaceutical Research Inc. in Juncos, PR, was inspected by the FDA from October 15-18, 2024. The inspection revealed a significant issue regarding the firm's failure to investigate unexplained discrepancies in batch production and control records. Specifically, unvalidated equipment was used during the manufacturing of Tramadol Extended Release Capsules without proper investigation or scientific justification.

## Related Documents

- [483 - 2021-06-01](https://www.globalkeysolutions.net/records/483/galephar-pharmaceutical-research-inc/c2ebc29d-a183-42e3-84aa-6f364ae9f774)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)
- [Christian F. Gomez Lugo](https://www.globalkeysolutions.net/people/christian-f-gomez-lugo/866e531a-6354-45b2-8e43-1dfc9d146caf)

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

Office: https://www.globalkeysolutions.net/offices/san-juan-district-office/27661cbf-5ba6-4c1b-9b39-4d6df63ca0e8