FDA Inspection
PPE Mask USA LLCPPE Mask USA LLC – FDA Inspection, Feb 22, 2022
Record Details
This FDA Inspection record concerns PPE Mask USA LLC, with an inspection on February 22, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- PPE Mask USA LLC
- Inspection Date
- February 22, 2022
- Product Type
- Devices
View Company Profile
ID · 941a3b84-e9ec-4e68-a0e3-36aaebaef4bd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1163469
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.25(b)Training records
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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