FDA Inspection
United Laboratories Manufacturing, LLCUnited Laboratories Manufacturing, LLC – FDA Inspection, Aug 12, 2010
Record Details
This FDA Inspection record concerns United Laboratories Manufacturing, LLC, with an inspection on August 12, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 12, 2010
- Product Type
- Drugs
View Company Profile
ID · 61d4486a-0935-4b1a-9de8-ea0cc91e221d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 675429
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.75(i)Corrective action plan
- 21 CFR 111.553Written procedures - product complaint
- 21 CFR 111.365(a)Conditions, controls -protect; microorganisms, contamination
Full citation text and observation details available on the Dashboard.
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 |
Other documents for United Laboratories Manufacturing, LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.