FDA Inspection 1059203 — Helena Laboratories UK Ltd
The FDA completed an inspection of Helena Laboratories UK Ltd on Jul 18, 2018 in Gateshead Newcastle. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 18, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Gateshead Newcastle (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |