FDA Inspection
Exmoor Plastics Ltd.Exmoor Plastics Ltd. – FDA Inspection, Aug 4, 2011
Record Details
This FDA Inspection record concerns Exmoor Plastics Ltd., with an inspection on August 4, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Exmoor Plastics Ltd.
- Inspection Date
- August 4, 2011
- Product Type
- Devices
View Company Profile
ID · 5ab4e460-2470-4328-9f75-c690536b6c62
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 741931
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Exmoor Plastics Ltd.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| December 5, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 29, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 3, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 25, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 24, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Exmoor Plastics Ltd.
- FDA Inspection 1113203 - 2019-12-05
- FDA Inspection 897329 - 2014-08-29
- FDA Inspection 743024 - 2011-08-03
- FDA Inspection 596745 - 2009-06-25
- FDA Inspection 596965 - 2009-06-24
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