Drug factory · FDA FEI 3003068480
Galephar Pharmaceutical Research Inc
Rd 198 Ste 100 Km 14.7, Juncos, PR, Puerto Rico
Problems found, fixed voluntarily at FDA's last inspection, Oct 18, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2008: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxycodone | Makes it | Ohemo Life Sciences Inc., Protega Pharmaceuticals Inc | 73780-001, 73780-002, 73780-003 +5 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 18, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Nov 23, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Sep 29, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jun 4, 2010 | No problems found | Drug Quality Assurance | — |
| Jan 30, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 12, 2008 | No problems found | 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.
Oct 18, 2024 inspection
- Investigations made into any unexplained discrepancy 21 CFR 211.188(b)(12)
Batch production and control records do not include the results of any investigation made into any unexplained discrepancy, whether or not the batch of drug product had already been distributed.
Nov 23, 2015 inspection
- Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
Sep 29, 2011 inspection
- Approve or reject components, products 21 CFR 211.22(a)
The quality control unit lacks the responsibility and authority to reject all in process materials.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack; particle size reduction; relabel; repack.