[SPECIAL] Checklist for Medical Device Manufacturers Subject to FDA Inspections

IT IS A MUST READ FOR MEDICAL DEVICE MANUFACTURERS.

This FDA inspection checklist (“Checklist”) has been developed for medical device manufacturers including in vitro diagnostic device (IVD) manufacturers based on over six thousand (6000) 483s issued for the past seven (7) years.

The Checklist shows the detailed regulatory sections (e.g., 21 CFR sections, 21 CFR 820.100(a)(1)) ranked from No. 1 through over 300 items based on the frequency of citations in 483s as shown in the following snapshot (for example, ranked number 9 (item number 9): 752 times cited).

2013-06-04_FDA-inspection-checklist-snapshot-medical-devices

“This Checklist is the best source and guidance for the medical device industry when preparing for an FDA inspection.  If you know what is being cited in 483s well in advance, you can most efficiently and effectively prepare for the FDA inspection and can avoid 483s.”

– President and Principal of REGULATORY DOCTOR

This Checklist provides the following information.

  • Over three hundred (300) items of regulatory sections cited in 483s (e.g., 21 CFR 820.198(a)) for the past seven (7) years.
  • Cited frequency of the regulatory sections (e.g., 21 CFR 820.50 – 494 times)
  • Description of violations
  • An electronic copy of 21 CFR Part 820 (also known as Quality System Regulations (QSRs) and cGMP for medical devices).
  • Upon payment confirmation, the checklist is delivered via email within 24 hours.
  • Price:  $199

NOTE: A credit card or PayPal is acceptable.

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