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Elite Laboratories has been given a warning letter due to a failure to develop adequate written procedures, particularly for adverse drug experiences (ADEs). Read More
The FDA is looking to increase its post-marketing inspections of manufacturing facilities, mainly within six months to two years after an approval, focused on ensuring that quality is maintained after a company scales up to commercial production. Read More
Cheng Fong Chemical received a warning letter from the FDA for dirty equipment, poorly maintained facilities and improper investigations into possibly tainted batches of active pharmaceutical ingredients. Read More
Hebei Yuxing Bio-Engineering, a Chinese producer of active pharmaceutical ingredients, received a warning letter from the FDA citing significant cGMP and data integrity issues discovered at its manufacturing plant. Read More
Option Care Enterprises received a warning letter from the FDA due to deficiencies in the production of sterile drugs and infusion products at its facility in Everett, Wash. Read More
Lima & Pergher Industria failed to provide stability data to ensure its drug products’ expiration dates and did not perform microbiological testing on each finished product, the FDA said in a warning letter to the Brazilian company. Read More