FDA Inspection
Bluepharma Industria Farmaceutica, S.A.Bluepharma Industria Farmaceutica, S.A. – FDA Inspection, May 24, 2019
Record Details
This FDA Inspection record concerns Bluepharma Industria Farmaceutica, S.A., with an inspection on May 24, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Angela E. Glenn (Issuing Officer)
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ID · c4c9592f-d347-4177-924f-573aafeade61
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1090994
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(4)Written calibration procedures
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
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Other FDA inspections of Bluepharma Industria Farmaceutica, S.A.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 13, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 28, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 24, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 26, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 8, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Bluepharma Industria Farmaceutica, S.A.
- FDA Inspection 1226152 - 2022-05-13
- FDA Inspection 993040 - 2016-10-28
- FDA Inspection 893007 - 2014-07-24
- FDA Inspection 801000 - 2012-07-26
- FDA Inspection 624356 - 2009-10-08
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