FDA Inspection 969056 — Hameln RDS S.R.O.
The FDA completed an inspection of Hameln RDS S.R.O. on Apr 22, 2016 in Modra. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 22, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Modra (Slovakia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |