FDA Inspection
Airpal, Inc.Airpal, Inc. – FDA Inspection, Mar 2, 2010
Record Details
This FDA Inspection record concerns Airpal, Inc., with an inspection on March 2, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Airpal, Inc.
- Inspection Date
- March 2, 2010
- Product Type
- Devices
View Company Profile
ID · 799a406d-7ea2-4302-8c84-383af6155e3c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 649104
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.198(a)General
- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records
- 21 CFR 820.20(b)(3)(i)Management representative implementing the quality system
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Airpal, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 2, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 25, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 23, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 9, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Airpal, Inc.
- FDA Inspection 1141355 - 2021-03-02
- FDA Inspection 943484 - 2015-09-25
- FDA Inspection 764169 - 2012-01-23
- FDA Inspection 721897 - 2011-05-09
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