FDA Inspection
Certified Laboratories LLCCertified Laboratories LLC – FDA Inspection, May 20, 2022
Record Details
This FDA Inspection record concerns Certified Laboratories LLC, with an inspection on May 20, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Certified Laboratories LLC
- Inspection Date
- May 20, 2022
- Product Type
- Drugs
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ID · 78edb2ae-3bfe-40a9-8a5f-2b9067514ef2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1169951
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.165(e)Test methods
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Other FDA inspections of Certified Laboratories LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 31, 2025 | VAI | Dallas District Office | Drug Quality Assurance |
| November 29, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 27, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 2, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Certified Laboratories LLC
- FDA Inspection 1261056 - 2025-01-31
- FDA Inspection 994050 - 2016-11-29
- FDA Inspection 707191 - 2011-01-27
- FDA Inspection 648650 - 2010-02-02
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