FDA Inspection
United Laboratories Manufacturing, LLCUnited Laboratories Manufacturing, LLC – FDA Inspection, Aug 16, 2012
Record Details
This FDA Inspection record concerns United Laboratories Manufacturing, LLC, with an inspection on August 16, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 16, 2012
- Product Type
- Drugs
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ID · 8b43a421-996c-4359-9e44-60fd214fe4ab
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 796232
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
21- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.182Personnel dating/signing equipment log
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of United Laboratories Manufacturing, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 15, 2025 | VAI | Dallas District Office | Drug Quality Assurance |
| March 7, 2025 | Not classified | Dallas District Office | |
| May 9, 2023 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| April 9, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 26, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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