FDA Inspection
Pemco IncPemco Inc – FDA Inspection, Oct 25, 2016
Record Details
This FDA Inspection record concerns Pemco Inc, with an inspection on October 25, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a3a23542-df33-48cb-be69-ac3a18b3a873
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 990485
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 806.10(b)Time to report - 10 days
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
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Other FDA inspections of Pemco Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 25, 2024 | NAI | Cincinnati District Office | Postmarket Assurance: Medical Devices |
| December 16, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 5, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 27, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Pemco Inc
- FDA Inspection 1253296 - 2024-10-25
- FDA Inspection 1158882 - 2021-12-16
- FDA Inspection 809014 - 2012-12-05
- FDA Inspection 659810 - 2009-04-27
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