FDA Inspection
Petoskey Plastics, Inc.Petoskey Plastics, Inc. – FDA Inspection, Apr 10, 2019
Record Details
This FDA Inspection record concerns Petoskey Plastics, Inc., with an inspection on April 10, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 4d7f7aeb-5965-43d3-8c1b-5aae0db055b0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1085889
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
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Other FDA inspections of Petoskey Plastics, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 6, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Petoskey Plastics, Inc.
- FDA Inspection 890125 - 2014-08-06
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