Drug factory · FDA FEI 1000113139
Rockledge Pharmaceutical Manufacturing, LLC
417 Richard Road, Rockledge, FL, United States
Problems found, fixed voluntarily at FDA's last inspection, Apr 24, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2009: 0 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Fluorouracil | Makes it | Mayne Pharma Inc. | 51862-362 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 24, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jan 25, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| May 19, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 20, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 16, 2009 | 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.
Apr 24, 2025 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components and in-process materials conform to appropriate standards of identity, strength, quality and purity.
Jan 25, 2019 inspection
- Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
Registered with FDA for: analysis; manufacture.