FDA Inspection
Quasar Bio-Tech, Inc.Quasar Bio-Tech, Inc. – FDA Inspection, Mar 6, 2013
Record Details
This FDA Inspection record concerns Quasar Bio-Tech, Inc., with an inspection on March 6, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Quasar Bio-Tech, Inc.
- Inspection Date
- March 6, 2013
- Product Type
- Devices
View Company Profile
ID · adab855b-da28-4720-b6fa-da52890332cf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 821318
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(d)Records of MDR Investigation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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Other FDA inspections of Quasar Bio-Tech, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| December 20, 2024 | NAI | Los Angeles District Office | Postmarket Assurance: Medical Devices |
| April 12, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 13, 2018 | VAI | Center for Devices and Radiological Health | Project Evaluation: Devices |
| May 6, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 3, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Quasar Bio-Tech, Inc.
- FDA Inspection 1257384 - 2024-12-20
- FDA Inspection 1089802 - 2019-04-12
- FDA Inspection 1048651 - 2018-04-13
- FDA Inspection 877630 - 2014-05-06
- FDA Inspection 708582 - 2011-02-03
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