There were six warning letter postings during this week, including one regarding Akorn’s site in Somerset, NJ that the company announced a few weeks ago.
GMP expert Barbara W. Unger provides her assessment of CDER’s State of Pharmaceutical Quality Report.
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.