This week’s postings included two to drug manufacturers and three to device manufacturers. FDA cites numerous repeat observations from previous inspections.
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.
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.
This was a very light week for warning letters with a total of two new ones posted by FDA. One was issued to a device manufacturer and we cover it here.
This week FDA posted 11 warning letters to dietary supplement manufacturers, two to pharma firms and one to a compounding pharmacy. We cover these last three.
We cover two warning letters to compounding pharmacies. The FDA still has not published the warning letter issued to Lupin Pharmaceuticals that the firm disclosed a few weeks ago.
Enforcement was busy this week. There were six warning letters sent to drug product manufacturers and one to an in vitro diagnostics firm.
We cover four warning letters from last week, including two to pharmaceutical firms and two to compounding facilities.