Rockledge Pharmaceutical Manufacturing LLC FDA Record
Rockledge Pharmaceutical Manufacturing LLC has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Rockledge Pharmaceutical Manufacturing LLC" is on file.
- Latest inspection
- Apr 24, 2025 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 5 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 24, 2025 | Rockledge, FL | Drugs | Voluntary Action Indicated (VAI) | 1000113139 |
| Jan 25, 2019 | Rockledge, FL | Drugs | Voluntary Action Indicated (VAI) | 1000113139 |
| May 19, 2016 | Rockledge, FL | Drugs | Voluntary Action Indicated (VAI) | 1000113139 |
| Jun 20, 2013 | Rockledge, FL | Drugs | Voluntary Action Indicated (VAI) | 1000113139 |
| Jul 16, 2009 | Rockledge, FL | Drugs | Voluntary Action Indicated (VAI) | 1000113139 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1000113139 | Rockledge, FL | 5 | Apr 24, 2025 |
Rockledge Pharmaceutical Manufacturing LLC and the FDA: common questions
Has Rockledge Pharmaceutical Manufacturing LLC received an FDA warning letter?
No FDA warning letter addressed to the name "Rockledge Pharmaceutical Manufacturing LLC" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Rockledge Pharmaceutical Manufacturing LLC received an FDA Form 483?
FDA has not published a Form 483 for "Rockledge Pharmaceutical Manufacturing LLC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Rockledge Pharmaceutical Manufacturing LLC?
The most recent FDA inspection on file ended Apr 24, 2025 at Rockledge, FL and was classified VAI. FDA has 5 inspections of Rockledge Pharmaceutical Manufacturing LLC on file.
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