Fda Inspection Checklist Medical Device

Pdf printer version 331 kb program 7383 001.

Fda inspection checklist medical device.

Proactively find gaps and correct non compliance with these customizable digital audit templates. Fda s office of regulatory affairs ora is the lead office for all field activities including inspections and enforcement. Guide to inspections of medical device manufacturers. Have a good qms in place and keep it up to date as well as keeping up with your management reviews and internal inspections.

A checklist for responding to fda 483 observations and warning letters. Fda audit checklist when fda calls to schedule a site visit obtain the following information. Device studies all versions. Refuse to accept policy for 510 k s describes the criteria fda intends to use in assessing a 510 k submission for review.

The food and drug administration fda conducts inspections and assessments of regulated facilities to determine a firm s compliance with applicable laws and regulations such as the food drug. R compliance program guidance manual for inspection of medical device manufacturers cp 7382 845. Medical device premarket approval and postmarket inspections. Fda medical device inspections fda small business regulatory education for industry redi silver spring maryland september 30 2015 marc neubauer.

Checklist to be done prior to inspection if possible. Step 1 gather and review study documentation detailed list follows. This document does not bind fda and does not confer any rights privileges benifits or. During an inspection ora investigators may observe conditions they.

Preparation checklist 2 fda inspection food manufacturing 3 fda audit pharmaceutical gmp checklist 4 fda gmp cosmetics audit checklist 5 gmp compliance checklist. Guide to inspections of.