FDA Inspection
DNTLworks Equipment Corp.DNTLworks Equipment Corp. – FDA Inspection, Jul 20, 2015
Record Details
This FDA Inspection record concerns DNTLworks Equipment Corp., with an inspection on July 20, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DNTLworks Equipment Corp.
- Inspection Date
- July 20, 2015
- Product Type
- Devices
View Company Profile
ID · ba6a1995-8e27-4298-93ea-dbd8c95b279d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 935561
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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