FDA Inspection 1004972 — PolarSeal Tapes And Conversions, Ltd.
The FDA completed an inspection of PolarSeal Tapes And Conversions, Ltd. on Feb 2, 2017 in Saxmundham. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 2, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Saxmundham (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3149 | 21 CFR 820.180 | Availability |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |