FDA Inspection
IMI TAMI Institute for Research & Development LtdIMI TAMI Institute for Research & Development Ltd – FDA Inspection, Dec 8, 2022
Record Details
This FDA Inspection record concerns IMI TAMI Institute for Research & Development Ltd, with an inspection on December 8, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 8, 2022
- Product Type
- Drugs
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ID · 1e81a46c-72b9-49b7-9dca-82743150244b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1192307
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
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Other FDA inspections of IMI TAMI Institute for Research & Development Ltd
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 14, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for IMI TAMI Institute for Research & Development Ltd
- FDA Inspection 822660 - 2012-12-11
- FDA Inspection 618020 - 2009-09-14
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