FDA Inspection
GP Pharm SAGP Pharm SA – FDA Inspection, May 21, 2019
Record Details
This FDA Inspection record concerns GP Pharm SA, with an inspection on May 21, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
- People
- Cheryl A. Clausen
- Zhihao Pete Qiu (Issuing Officer)
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ID · 9007b864-97a5-4e91-b3db-d9515b083a72
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1091594
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.110(b)In-process conformity - examination, sample testing
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of GP Pharm SA
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 21, 2023 | VAI | Drug Quality Assurance | |
| October 2, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 20, 2018 | Not classified | Office of Inspections and Investigations | |
| January 24, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 27, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for GP Pharm SA
- FDA Inspection 1305252 - 2023-09-21
- FDA Inspection 1149441 - 2020-10-02
- FDA Inspection 1062872 - 2018-06-20
- FDA Inspection 1004446 - 2017-01-24
- FDA Inspection 917365 - 2015-01-27
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