FDA Inspection
Bieffe Medital, S.A.Bieffe Medital, S.A. – FDA Inspection, Feb 23, 2014
Record Details
This FDA Inspection record concerns Bieffe Medital, S.A., with an inspection on February 23, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Bieffe Medital, S.A.
- Inspection Date
- February 23, 2014
- Product Type
- Drugs
View Company Profile
ID · d1259e02-0310-4d7d-a771-feea1663f7e4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 869230
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.42(b)Product flow through building is inadequate
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Bieffe Medital, S.A.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 11, 2025 | VAI | Drug Quality Assurance | |
| April 22, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 20, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Bieffe Medital, S.A.
- FDA Inspection 1304716 - 2025-04-11
- FDA Inspection 1146372 - 2021-04-22
- FDA Inspection 988856 - 2016-07-20
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