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FDA Inspection
•Pro Trainers' Choice Company, Inc.•May 5, 2011

Pro Trainers' Choice Company, Inc. – FDA Inspection, May 5, 2011

Record Details

This FDA Inspection record concerns Pro Trainers' Choice Company, Inc., with an inspection on May 5, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company
Pro Trainers' Choice Company, Inc.
Inspection Date
May 5, 2011
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 11fa81c8-dba8-4583-bdfc-38491ad331a6

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
726452
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

6
  1. 21 CFR 820.100(a)Lack of or inadequate procedures
  2. 21 CFR 820.30(a)Design control - no procedures
  3. 21 CFR 820.184Lack of or inadequate DHR procedures
  4. 21 CFR 820.22Quality audits - Lack of or inadequate procedures
  5. 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
  6. 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Pro Trainers' Choice Company, Inc.

1
DateClassificationOfficeProject area
January 17, 2014NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
Other documents for Pro Trainers' Choice Company, Inc.
  • FDA Inspection 863487 - 2014-01-17

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