FDA Inspection
Bial Portela & Ca. S.A.Bial Portela & Ca. S.A. – FDA Inspection, Jun 21, 2024
Record Details
This FDA Inspection record concerns Bial Portela & Ca. S.A., with an inspection on June 21, 2024, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 9ca149f9-5acb-4da8-bdfc-271af0ca4a1b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1242424
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bial Portela & Ca. S.A.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 6, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 10, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 12, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 12, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 15, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Bial Portela & Ca. S.A.
- FDA Inspection 1278112 - 2022-05-06
- FDA Inspection 1115591 - 2019-05-10
- FDA Inspection 950439 - 2015-11-12
- FDA Inspection 810978 - 2012-12-12
- FDA Inspection 616316 - 2009-09-15
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