FDA Inspection
United Laboratories Manufacturing, LLCUnited Laboratories Manufacturing, LLC – FDA Inspection, Aug 15, 2025
Record Details
This FDA Inspection record concerns United Laboratories Manufacturing, LLC, with an inspection on August 15, 2025, issued by the Dallas District Office, covering human drugs.
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ID · 45463719-0a0c-4a63-a816-57e188c6a316
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1251234
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued, view the record
FDA Citations
8- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.130(a)Prevention of cross contamination, mix-ups
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Other FDA inspections of United Laboratories Manufacturing, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| August 16, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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