FDA Inspection
H & A Mui Enterprises, Inc.H & A Mui Enterprises, Inc. – FDA Inspection, Aug 5, 2011
Record Details
This FDA Inspection record concerns H & A Mui Enterprises, Inc., with an inspection on August 5, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- H & A Mui Enterprises, Inc.
- Inspection Date
- August 5, 2011
- Product Type
- Devices
View Company Profile
ID · 26253b12-a11a-401e-bad0-8bf190d83314
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 744716
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.80(c)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
- 21 CFR 803.17(b)(1)Info evaluated to determine if event was reportable
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Other FDA inspections of H & A Mui Enterprises, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 23, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for H & A Mui Enterprises, Inc.
- FDA Inspection 935453 - 2015-07-23
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