FDA Inspection
Antibiotice S.A.Antibiotice S.A. – FDA Inspection, Mar 14, 2017
Record Details
This FDA Inspection record concerns Antibiotice S.A., with an inspection on March 14, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Doan N. Singh (Issuing Officer)
- Meisha R. Sampson (Issuing Officer)
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ID · b3c980b7-63ab-4a56-a1cf-0227573d28a9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1007402
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Antibiotice S.A.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 14, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 11, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 22, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 9, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Antibiotice S.A.
- FDA Inspection 1245118 - 2022-10-14
- FDA Inspection 1136125 - 2019-10-11
- FDA Inspection 818053 - 2013-01-22
- FDA Inspection 713355 - 2010-11-09
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