FDA Inspection
Mitim SRLMitim SRL – FDA Inspection, May 10, 2016
Record Details
This FDA Inspection record concerns Mitim SRL, with an inspection on May 10, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Mitim SRL
- Inspection Date
- May 10, 2016
- Product Type
- Drugs
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ID · 922b4b4f-52b2-49cb-bb99-a9edd456aada
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 974363
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
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Other FDA inspections of Mitim SRL
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 18, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 16, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 24, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 1, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 15, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Mitim SRL
- FDA Inspection 1266236 - 2023-05-18
- FDA Inspection 1109041 - 2018-11-16
- FDA Inspection 1062263 - 2018-07-24
- FDA Inspection 878874 - 2014-04-01
- FDA Inspection 753774 - 2011-11-15
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