FDA Inspection
LabChemS Corp.LabChemS Corp. – FDA Inspection, Oct 6, 2016
Record Details
This FDA Inspection record concerns LabChemS Corp., with an inspection on October 6, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 076e0110-d257-4bce-ac2f-3cc9d03d356f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 987238
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of LabChemS Corp.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 8, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 22, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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