FDA Inspection
Palmero Sales Company, Inc.Palmero Sales Company, Inc. – FDA Inspection, Feb 6, 2013
Record Details
This FDA Inspection record concerns Palmero Sales Company, Inc., with an inspection on February 6, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Palmero Sales Company, Inc.
- Inspection Date
- February 6, 2013
- Product Type
- Devices
View Company Profile
ID · 49b43823-4259-46d2-aec0-51cc6cef8b1a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 817809
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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