We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
An FDA inspection found microbiological contamination of drugs purporting to be sterile at a Bausch & Lomb manufacturing facility in Florida, according to a Form 483 handed to the company. 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
The European Medicines Agency has recommended that three medicines manufactured by Pharmaceuticals International Inc. (PII) no longer be available in the EU due to possible cross-contamination. 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
Despite significant potential savings in time and money, drug and medical device manufacturers have been slow to embrace continuous manufacturing, an FDA technology official said. Read More
A year from now, each drug product processed and moved through the U.S. supply chain could have its own unique identifier under the Drug Supply Security Act, FDA and industry officials said at a meeting Monday. Read More