FDA Inspection
Asahi Kasei Medical America Inc Memphis Distribution CenterAsahi Kasei Medical America Inc Memphis Distribution Center – FDA Inspection, Jan 11, 2018
Record Details
This FDA Inspection record concerns Asahi Kasei Medical America Inc Memphis Distribution Center, with an inspection on January 11, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 11, 2018
- Product Type
- Devices
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ID · b17c27c8-8d9d-4a2c-937e-f7990fccdc39
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1037688
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.20(a)Quality policy and objectives
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