FDA Inspection
Pierrel S.p.A.Pierrel S.p.A. – FDA Inspection, Jun 6, 2014
Record Details
This FDA Inspection record concerns Pierrel S.p.A., with an inspection on June 6, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Pierrel S.p.A.
- Inspection Date
- June 6, 2014
- Product Type
- Drugs
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ID · bb399813-956c-4740-a011-15f81d767ff4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 886492
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.122(c)Records fail to include
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Pierrel S.p.A.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 23, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 15, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 26, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 5, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 31, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Pierrel S.p.A.
- FDA Inspection 1261179 - 2023-03-23
- FDA Inspection 1202410 - 2019-02-15
- FDA Inspection 1059983 - 2018-06-26
- FDA Inspection 779674 - 2012-03-05
- FDA Inspection 601996 - 2009-07-31
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