FDA Inspection
Debiopharm Research & Manufacturing S.A.Debiopharm Research & Manufacturing S.A. – FDA Inspection, Mar 14, 2023
Record Details
This FDA Inspection record concerns Debiopharm Research & Manufacturing S.A., with an inspection on March 14, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 3acc693d-327d-45f5-a2d5-517adc842b32
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1199737
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Debiopharm Research & Manufacturing S.A.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 8, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 7, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 18, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 7, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Debiopharm Research & Manufacturing S.A.
- FDA Inspection 1055095 - 2018-06-08
- FDA Inspection 987836 - 2016-09-07
- FDA Inspection 870230 - 2014-03-18
- FDA Inspection 590703 - 2009-05-07
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