Drug factory · FDA FEI 3008206797
Galephar Pharmaceutical Research Inc.
Rd 925 Km 6.1 Bo Junquito, , Humacao, PR, United States
No problems found at FDA's last inspection, Jun 5, 2025.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2012: 3 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Isotretinoin | Makes it, tests it and packages it | Caraco Pharmaceutical Laboratories, Ltd., Galephar Pharmaceutical Research Inc. | 10631-115, 10631-116, 10631-117 +13 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 5, 2025 | No problems found | Drug Quality Assurance | — |
| Nov 1, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jun 11, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
| Jun 11, 2015 | No problems found | Bioresearch Monitoring | 6 |
| Jan 15, 2013 | No problems found | Drug Quality Assurance | — |
| May 7, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Nov 1, 2019 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Jun 11, 2015 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed. - Adequate space lacking to prevent mix-ups and contamination 21 CFR 211.42(b)
The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between drug product containers, in-process materials, and drug products and to prevent contamination. - Adequate space lacking to prevent mix-ups and contamination 21 CFR 211.42(b)
The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between drug product containers, in-process materials, and drug products and to prevent contamination. - Sanitation--buildings not clean, free of infestation 21 CFR 211.56(a)
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition. - Sanitation--buildings not clean, free of infestation 21 CFR 211.56(a)
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack; particle size reduction; relabel; repack.