The only good part of receiving an FDA warning letter is when a company gets a closeout letter that says it has finally met FDA expectations. It has taken three years, but generics maker CorePharma says it has gotten its closeout for a plant in New Jersey.
The generic drug manufacturer, which for nearly two years had its products banned from the U.S., has received a warning letter for two of its in Canada plants, one in Ontario and one in Toronto that has received a warning letter before.
Plant problems don't always mean an interruption of production of existing product. Sometimes they can keep a new drug from potentially getting to market, Impax Pharmaceuticals has found.
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.