FDA Inspection
Maude Group Inc.FDA Inspection 1120903 - Maude Group Inc. - March 13, 2020
Record Details
This FDA Inspection record concerns Maude Group Inc., with an inspection on March 13, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Maude Group Inc.
- Inspection Date
- March 13, 2020
- Product Type
- Devices
View Company Profile
ID · 5be70bd2-d995-4a65-8435-5495b0a2b0ab
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1120903
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 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 820.50(a)Evaluation of suppliers, contractors, etc., requirements
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