FDA Inspection
Omega Tech Labs, LLCOmega Tech Labs, LLC – FDA Inspection, Aug 25, 2016
Record Details
This FDA Inspection record concerns Omega Tech Labs, LLC, with an inspection on August 25, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Omega Tech Labs, LLC
- Inspection Date
- August 25, 2016
- Product Type
- Drugs
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ID · 4243666a-83b0-44a7-9026-ce6732a02402
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 986391
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.166(b)Accelerated stability studies
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.188(a)Accurate reproduction
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Omega Tech Labs, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 30, 2025 | OAI | Seattle District Office | Drug Quality Assurance |
| January 22, 2024 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 3, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 2, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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