FDA Inspection
TMIG IncTMIG Inc – FDA Inspection, Mar 11, 2019
Record Details
This FDA Inspection record concerns TMIG Inc, with an inspection on March 11, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Gideon N. Esuzor (FDA Associated Person)
- Rachael L. Derby (Issuing Officer)
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ID · aa6255ab-9ca9-46cc-b8c3-40f9512c31a0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1082253
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.198(a)Reporting of adverse drug experience to FDA
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Other FDA inspections of TMIG Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 29, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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