FDA Inspection
Isomers Laboratories Inc.Isomers Laboratories Inc. – FDA Inspection, Sep 25, 2019
Record Details
This FDA Inspection record concerns Isomers Laboratories Inc., with an inspection on September 25, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 3b0176d8-a38a-4955-925c-767b514aa137
Inspection Facts
- Inspection number
- 1102733
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
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Other FDA inspections of Isomers Laboratories Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 11, 2018 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 29, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 29, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Isomers Laboratories Inc.
- FDA Inspection 1054191 - 2018-05-11
- FDA Inspection 884454 - 2014-05-29
- FDA Inspection 752282 - 2011-09-29
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