FDA Inspection
Propper Mfg Co IncPropper Mfg Co Inc – FDA Inspection, Dec 21, 2017
Record Details
This FDA Inspection record concerns Propper Mfg Co Inc, with an inspection on December 21, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bcef571b-c9dd-4072-86f4-fc70d970192f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1035639
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.86Acceptance status
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Other FDA inspections of Propper Mfg Co Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 13, 2024 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 14, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 18, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 3, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 27, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Propper Mfg Co Inc
- FDA Inspection 1242777 - 2024-06-13
- FDA Inspection 1152179 - 2021-09-14
- FDA Inspection 918916 - 2015-03-18
- FDA Inspection 802483 - 2012-10-03
- FDA Inspection 696082 - 2010-10-27
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