IT IS A MUST READ FOR DRUG MANUFACTURERS.
This FDA inspection checklist (“Checklist”) has been developed for drug manufacturers based on over four thousand (4000) 483s issued for the past seven (7) years.
The Checklist shows the detailed regulatory sections (e.g., 21 CFR sections, 21 CFR 211.192) ranked from No. 1 through over 290 items based on the frequency of citations in 483s as shown in the following snapshot (for example, ranked number 41 (item number 41): 150 times cited).
“This Checklist is the best source and guidance for the drug industry when preparing for an FDA inspection to avoid 483s. 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 two hundred (200) items of regulatory sections cited in 483s (e.g., 21 CFR 211.22(d)) for the past seven (7) years.
- Cited frequency of the regulatory sections (e.g., 21 CFR 211.22(d) – 1081 times)
- Description of violations
- Checklist is available (Excel file or PDF)
- Upon payment confirmation, the checklist is delivered via email within 24 hours.
- Price: $199
NOTE: A credit card or PayPal is acceptable.