FDA Inspection
Omega Biological Laboratories Inc.Omega Biological Laboratories Inc. – FDA Inspection, Jul 9, 2010
Record Details
This FDA Inspection record concerns Omega Biological Laboratories Inc., with an inspection on July 9, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 9, 2010
- Product Type
- Drugs
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ID · aaddc742-3f75-4460-b863-5c53b5dafa3c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 672552
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.160(a)Lab controls established, including changes
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Other FDA inspections of Omega Biological Laboratories Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 31, 2025 | VAI | New Jersey District Office | Drug Quality Assurance |
| November 7, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 25, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 14, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 15, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Omega Biological Laboratories Inc.
- FDA Inspection 1277045 - 2025-07-31
- FDA Inspection 1071303 - 2018-11-07
- FDA Inspection 884889 - 2014-06-25
- FDA Inspection 779782 - 2012-05-14
- FDA Inspection 730031 - 2011-06-15
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