FDA Inspection
Virulite LlcVirulite Llc – FDA Inspection, Apr 27, 2022
Record Details
This FDA Inspection record concerns Virulite Llc, with an inspection on April 27, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Virulite Llc
- Inspection Date
- April 27, 2022
- Product Type
- Devices
View Company Profile
ID · eeed1ebc-4c15-4234-aeb4-ef8d6d93ba87
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1168374
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.30(a)Design control - no procedures
- 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 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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