FDA Inspection
Omega Tech Labs, LLCOmega Tech Labs, LLC – FDA Inspection, Apr 3, 2013
Record Details
This FDA Inspection record concerns Omega Tech Labs, LLC, with an inspection on April 3, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Omega Tech Labs, LLC
- Inspection Date
- April 3, 2013
- Product Type
- Drugs
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ID · 611e01d1-cbe7-4575-bb94-2120ec1ba95f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 823443
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.87Retest of approved components/containers/closures
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 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 |
| August 25, 2016 | 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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