FDA Inspection
Star Tech Health Services, IncStar Tech Health Services, Inc – FDA Inspection, Mar 31, 2011
Record Details
This FDA Inspection record concerns Star Tech Health Services, Inc, with an inspection on March 31, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 31, 2011
- Product Type
- Devices
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ID · f6f4b2c6-37ca-4f16-a92a-96dce7480cce
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 717538
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
17- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
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