FDA Inspection
Berlimed, S.A.Berlimed, S.A. – FDA Inspection, Sep 25, 2018
Record Details
This FDA Inspection record concerns Berlimed, S.A., with an inspection on September 25, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Vilmary Negron Rodriguez (Issuing Officer)
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ID · 94834c07-52d4-4a63-a010-0896ee7a5f5c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1066603
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.67(b)Written procedures fail to include
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Other FDA inspections of Berlimed, S.A.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 26, 2024 | Not classified | Office of Inspections and Investigations | |
| March 9, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 29, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 29, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 23, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Berlimed, S.A.
- FDA Inspection 1237531 - 2024-04-26
- FDA Inspection 1268490 - 2023-03-09
- FDA Inspection 1123968 - 2019-03-29
- FDA Inspection 959549 - 2016-01-29
- FDA Inspection 603530 - 2009-06-23
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