FDA Inspection
Rockledge Pharmaceutical Manufacturing LLCRockledge Pharmaceutical Manufacturing LLC – FDA Inspection, Jan 25, 2019
Record Details
This FDA Inspection record concerns Rockledge Pharmaceutical Manufacturing LLC, with an inspection on January 25, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c3ccfaa5-35f1-44ee-be5d-448e464ef6b6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1077088
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Rockledge Pharmaceutical Manufacturing LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 24, 2025 | VAI | Florida District Office | 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 1250752 - 2025-04-24
- FDA Inspection 973786 - 2016-05-19
- FDA Inspection 838341 - 2013-06-20
- FDA Inspection 597735 - 2009-07-16
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