Drug factory · FDA FEI 3012257735
Oxford Pharmaceuticals, LLC
301 Leaf Lake Parkway, Birmingham, AL, United States
Problems found, fixed voluntarily at FDA's last inspection, Nov 3, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2019: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 3, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Jun 8, 2022 | No problems found | Bioresearch Monitoring | — |
| May 22, 2019 | 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 3, 2023 inspection
- Establishment of time limitations 21 CFR 211.111
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity. - Authority lacking to review records, investigate errors 21 CFR 211.22(a)
The quality control unit lacks authority to fully investigate errors that have occurred. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Registered with FDA for: analysis; label; manufacture; pack.