FDA Inspection
GP Grenzach Produktions GmbHGP Grenzach Produktions GmbH – FDA Inspection, Jul 1, 2016
Record Details
This FDA Inspection record concerns GP Grenzach Produktions GmbH, with an inspection on July 1, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- GP Grenzach Produktions GmbH
- Inspection Date
- July 1, 2016
- Product Type
- Drugs
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ID · 8df12bbf-8fda-4924-84f2-5519f5f5331b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 990191
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 600.12(c)Sterilization of Equipment and Supplies
- 21 CFR 211.160(b)(2)In-process samples representative, identified properly
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 123.11(b)Sanitation monitoring
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Other FDA inspections of GP Grenzach Produktions GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 30, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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