FDA Inspection
Pall CorporationPall Corporation – FDA Inspection, Mar 1, 2019
Record Details
This FDA Inspection record concerns Pall Corporation, with an inspection on March 1, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · dfdd6126-f8c6-4eac-b4d8-0560758d74fc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1081151
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Pall Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 23, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 27, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 8, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 20, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Pall Corporation
- FDA Inspection 933075 - 2015-06-23
- FDA Inspection 824475 - 2013-03-27
- FDA Inspection 717008 - 2011-03-08
- FDA Inspection 572515 - 2009-02-20
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