Former FDA Investigator Peter Baker gives insight to MHRA’s GXP guide for data integrity.
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Part two of this series will walk through our tagging methodologies and analysis on data integrity keyword 483 citations over the last five years.
Enforcement included five warning letters to either homeopathic or OTC firms, continuing the FDA’s focus in this area. Fundamental GMPs seem to be missing.
Did you know that “data integrity” is the second most-cited keyword in CDER warning letters? Or that it ranks 33rd of 483 cited keywords?
Enforcement was light this week, including a single warning letter to a drug manufacturer in France. Laboratoires Clarins (Pontoise, France) received a warning letter on April 23, 2019 based on the outcome of an inspection ending September 21, 2018. FDA points the firm to the FDA guidance on the investigation of OOS events and process validation guidance. In addition, they recommend the firm hire qualified consultants to assist them in coming into compliance.
Enforcement was light on warning letters this week: one to a device manufacturer, one to a compounding pharmacy and one to a homeopathic drug manufacturer.
Have you clicked over to the FDA website recently? If so, you saw that the site has a whole new look and feel. After three years in the works, the US Food and Drug Administration (FDA) launched a more customer-centric website at FDA.gov that’s easier to search and view on all browser types and sizes. One thing to note is you may find old links to the site no longer work, “Most URLs will change. Automatic redirects will be established, but users should update their bookmarks,” the FDA spokesperson said. What does this mean for users of the FDAzilla platform and blog?
Preparing for GMP inspections, particularly pre-approval inspections, can be a challenge when resources are limited and staff may have little expertise in these important activities.
Two warning letters were issued last week to drug manufacturers. Both cite Quality Unit failures.
In April of 2019, we added 226 483s to our database of 27,500+ FDA inspection documents. (NOTE: Are you interested in learning more about observations with specific industry keywords? Get your FREE 483 Observation Report and you can quickly determine who has been hit with the same observations. Learn more here!)
Enforcement this week saw a single untitled letter to a stem cell facility (and 50-plus affiliates) and a warning letter to a compounding pharmacy.
Does the FDA cite the same data integrity keywords on warning letters as 483s? Not really.
This week’s postings included two to drug manufacturers and three to device manufacturers. FDA cites numerous repeat observations from previous inspections.