FDA Inspection
Renaissance Lakewood, LLCRenaissance Lakewood, LLC – FDA Inspection, Mar 7, 2012
Record Details
This FDA Inspection record concerns Renaissance Lakewood, LLC, with an inspection on March 7, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Renaissance Lakewood, LLC
- Inspection Date
- March 7, 2012
- Product Type
- Drugs
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ID · 75c13d1d-f6e8-485b-b1da-c3466d51fcc0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 770948
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.113(b)Validation lacking for sterile drug products
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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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