FDA Inspection
Sanovel Ilac Sanayi Ve Ticaret A.S.Sanovel Ilac Sanayi Ve Ticaret A.S. – FDA Inspection, Mar 24, 2023
Record Details
This FDA Inspection record concerns Sanovel Ilac Sanayi Ve Ticaret A.S., with an inspection on March 24, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c682e7a6-6c2b-4b4f-9281-80dabcb46aad
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1200759
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Sanovel Ilac Sanayi Ve Ticaret A.S.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2018 | Not classified | Office of Inspections and Investigations |
Other documents for Sanovel Ilac Sanayi Ve Ticaret A.S.
- FDA Inspection 1070487 - 2018-09-11
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