FDA Inspection
Renaissance Lakewood, LLCRenaissance Lakewood, LLC – FDA Inspection, Apr 28, 2010
Record Details
This FDA Inspection record concerns Renaissance Lakewood, LLC, with an inspection on April 28, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Renaissance Lakewood, LLC
- Inspection Date
- April 28, 2010
- Product Type
- Drugs
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ID · 78baaece-ee4c-444a-8d1f-88c9c7b96821
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 655482
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Renaissance Lakewood, LLC
13| Date | Classification | Office | Project area |
|---|---|---|---|
| July 29, 2026 | Not classified | New Jersey District Office | Drug Quality Assurance |
| June 6, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 22, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 15, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 26, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Renaissance Lakewood, LLC
- FDA Inspection 1327338 - 2026-07-29
- FDA Inspection 1209603 - 2023-06-06
- FDA Inspection 1100331 - 2019-08-22
- FDA Inspection 1045720 - 2018-03-15
- FDA Inspection 1009890 - 2017-04-26
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