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“You can only rely on a COA for other component attributes by validating the supplier’s test results at appropriate intervals,” the FDA said. Read More
The lengthy 483 also flagged quality unit shortcomings. Specifically, the company didn’t have written procedures for CAPAs or document management and control. Read More
New Jersey drugmaker A.P. Deauville received a warning letter from the FDA for repeat quality and cleaning violations for its OTC topical drugs. Read More
A contaminated water system at one of Torrent Pharmaceuticals’ U.S. manufacturing facilities — and inadequate investigations into failing microbiological results — resulted in a second FDA warning letter for the company in a single month. Read More
The FDA hit Japanese API and sterile drug manufacturer Shionogi with a Form 483 for deficiencies in its production batch records and cleaning procedures. Read More
Apothecus Pharmaceutical drew a warning letter from the FDA for quality and data integrity violations at its manufacturing facility in Hicksville, New York. Read More
The FDA’s Office of Prescription Drug Promotion hit Nascent Biotech with an untitled letter over claims on its website for the investigational brain cancer drug Pritumumab. Read More