FDA Inspection
Pierrel S.p.A.Pierrel S.p.A. – FDA Inspection, Mar 5, 2012
Record Details
This FDA Inspection record concerns Pierrel S.p.A., with an inspection on March 5, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Pierrel S.p.A.
- Inspection Date
- March 5, 2012
- Product Type
- Drugs
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ID · 87dac2fb-4ebd-49ed-a94c-024af475ad0a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 779674
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.167(a)Sterility/pyrogens - test methods written, followed
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.182Written records kept in individual logs
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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 |
| June 6, 2014 | 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 886492 - 2014-06-06
- FDA Inspection 601996 - 2009-07-31
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