In a recent FDA presentation Foster City, CA, Mark Roh, Regional Food and Drug Director outlined the most common cited 483 items for both pharma and med device companies:
The most common Drug GMP FDA-483 (observational) items:
- Responsibilities and procedures of the Quality Control unit are not in writing
- Written procedures are not followed
- Control procedures not established
- Inadequate specificatons
- inadequate written procedures
- Inadequate failure analysis
The most common Medical Device GMP FDA-483 (observational) items:
- Deficiencies in complaint file system
- Inadequate CAPA procedures
- Lack of written MDR procedures
- Corrective and preventive actions not documented
- Inadequate process validation
This doesn’t mean you won’t be cited for anything not listed in the bullet items or nabbed for all of the above. These are the most common observations cited by FDA personnel during an inspection. So now you may want to go back and take a good hard look at your SOPs, quality management system, CAPA process, complaint handling/MDRs as well as your validation documentation. Obviously training your personnel in these procedures and processes is also key.
Of course, everyone’s goal is not to end up here…
Also, you may want to check out our previous blog entry “Don’t Ignore 483s…it’s in Your Best Interest to Respond in Writing“
We’ve got a searchable listing of all the 483s since 2000 here:
http://www.fdazilla.com/fda/compliance/483/