FDA Inspection
International Biophysics Corp.International Biophysics Corp. – FDA Inspection, Aug 30, 2013
Record Details
This FDA Inspection record concerns International Biophysics Corp., with an inspection on August 30, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 30, 2013
- Product Type
- Devices
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ID · 4bab27ef-aebe-47c1-abb1-820675d4a01a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 849799
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.75(c)Documentation - review in response to changes or deviations
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Other FDA inspections of International Biophysics Corp.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 8, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 20, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for International Biophysics Corp.
- FDA Inspection 1030694 - 2017-06-08
- FDA Inspection 590899 - 2009-05-20
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