FDA Inspection
Homewood Healthcare Products Inc.Homewood Healthcare Products Inc. – FDA Inspection, Apr 21, 2016
Record Details
This FDA Inspection record concerns Homewood Healthcare Products Inc., with an inspection on April 21, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 21, 2016
- Product Type
- Devices
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ID · c11ac9e7-7373-4d87-a659-964494642dca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 967537
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184Lack of or inadequate DHR 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 820.20(e)Quality System Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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