FDA Inspection
GP Pharm SAGP Pharm SA – FDA Inspection, Jan 24, 2017
Record Details
This FDA Inspection record concerns GP Pharm SA, with an inspection on January 24, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d67f0658-9a83-4622-a757-b6a1542990ad
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1004446
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.42(c)(10)(i)Floors, walls, ceiling surfaces
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.84(d)(2)Component identification test
- 21 CFR 211.84(d)(3)Establish reliability of supplier's C of A
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
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 |
| May 21, 2019 | OAI | Office of Inspections and Investigations | Generic Drug Evaluation |
| June 20, 2018 | Not classified | Office of Inspections and Investigations | |
| 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 1091594 - 2019-05-21
- FDA Inspection 1062872 - 2018-06-20
- FDA Inspection 917365 - 2015-01-27
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