FDA Inspection
Rockledge Pharmaceutical Manufacturing LLCRockledge Pharmaceutical Manufacturing LLC – FDA Inspection, Apr 24, 2025
Record Details
This FDA Inspection record concerns Rockledge Pharmaceutical Manufacturing LLC, with an inspection on April 24, 2025, issued by the Florida District Office, covering human drugs.
- Inspection Date
- April 24, 2025
- Product Type
- Human Drugs
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ID · ac9a0fc8-e876-4b22-91ff-186bbc2dd56d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1250752
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.160(b)Scientifically sound laboratory controls
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Other FDA inspections of Rockledge Pharmaceutical Manufacturing LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 25, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 19, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 20, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 16, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Rockledge Pharmaceutical Manufacturing LLC
- FDA Inspection 1077088 - 2019-01-25
- FDA Inspection 973786 - 2016-05-19
- FDA Inspection 838341 - 2013-06-20
- FDA Inspection 597735 - 2009-07-16
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