FDA Inspection
Penlon LimitedPenlon Limited – FDA Inspection, Sep 13, 2018
Record Details
This FDA Inspection record concerns Penlon Limited, with an inspection on September 13, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c3677278-4836-41eb-97ab-b6ad74b63f0c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1065790
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
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Other FDA inspections of Penlon Limited
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 12, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 14, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 28, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Penlon Limited
- FDA Inspection 1258262 - 2024-12-12
- FDA Inspection 1178449 - 2022-07-14
- FDA Inspection 737706 - 2011-07-28
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