FDA Inspection 780895 — Pan Medical Ltd.
The FDA completed an inspection of Pan Medical Ltd. on May 10, 2012 in Gloucester. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 10, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Gloucester (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |