FDA Inspection
Inotech Biosystems Intl., IncInotech Biosystems Intl., Inc – FDA Inspection, Sep 17, 2009
Record Details
This FDA Inspection record concerns Inotech Biosystems Intl., Inc, with an inspection on September 17, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 17, 2009
- Product Type
- Devices
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ID · a4c74214-e5fa-492b-89cf-894b6bb502e0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 615080
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.198(a)General
- 21 CFR 803.18(d)(1)Distributor responsibilities for complaint records
- 21 CFR 820.100(b)Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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