FDA Inspection
Maclin Power Inc.Maclin Power Inc. – FDA Inspection, Dec 22, 2016
Record Details
This FDA Inspection record concerns Maclin Power Inc., with an inspection on December 22, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f28f094f-23b6-43c2-9062-6d8293be0143
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1001749
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.50(b)Supplier notification of changes
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