FDA Inspection
Kyowa Textile USA IncKyowa Textile USA Inc – FDA Inspection, Jun 21, 2019
Record Details
This FDA Inspection record concerns Kyowa Textile USA Inc, with an inspection on June 21, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · eeee0d28-f6d5-460e-847f-9e586eebbbae
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1093977
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 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 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 803.17Lack of Written MDR Procedures
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