FDA Inspection
Berlimed, S.A.Berlimed, S.A. – FDA Inspection, Jan 29, 2016
Record Details
This FDA Inspection record concerns Berlimed, S.A., with an inspection on January 29, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Berlimed, S.A.
- Inspection Date
- January 29, 2016
- Product Type
- Drugs
View Company Profile
ID · 157c3f16-6a6e-4292-8a35-56da96e069e2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 959549
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
Full citation text and observation details available on the Dashboard.
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 |
| September 25, 2018 | 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 1066603 - 2018-09-25
- FDA Inspection 603530 - 2009-06-23
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.