FDA inspectors have come down hard on a drugmaker in Taiwan, issuing a warning letter to Taiwan Three Mast Pharmaceutical in Tainan City for serious manufacturing violations.
Another injectable drug is being recalled after particles were seen in the finished product.
Issuing its defense of the part it has played in drug shortages, the FDA says it is very concerned about the problem but essentially tells Congress that it can't turn its head when drugmakers turn out substandard and contaminated products that are going to hurt patients.
Not following through to fix problems noted by FDA inspectors is sure to land manfuacturers in trouble with the FDA, and contract manufacturer Shamrock Medical Solutions has received a warning letter that proves it.
Insufficient equipment cleaning led a California API maker to recall several lots of Simethicone Emulsion USP (30%) that had microbial contamination.
The FDA issued warning letters to an API plant in Poland, a drug manufacturing plant in Mexico and a medical device manufacturer in China.
The FDA has raised serious concerns about the manufacturing and data security processes at a plant in the United Arab Emirates operated by Gulf Pharmaceutical Industries.
APP Pharmaceuticals ($APPX) has had its production of heparin called into question in an FDA warning letter and has been ordered to present three years worth of out-of-specification results for...
Integra LifeSciences, which manufacturers medical devices used in surgery, has been fighting a mold problem at its collagen manufacturing facility in Plainsboro, NJ, for more than two years, the FDA...
Analytics issues appear in the majority of FDA warning letter citations for manufacturing, including unvalidated methods and inadequate procedures for responding to out-of-spec test results. The...