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Joining three other Eugia Pharma plants in India, the company’s facility in Bhiwadi, Rajasthan, was handed a Form 483 from the FDA, citing observations of operators not following procedures in place to prevent microbial contamination of drug products, among other lapses. Read More
A 10-item Form 483 called out multiple problems with expired or non-pharmaceutical grade products, lack of written procedures and records, and an inadequate quality control unit at Maryland-based Aerosol and Liquid Packaging. Read More
Shouldering the cost of FY25 federal employee pay increases may cause the FDA’s Office of Regulatory Affairs (ORA) to reduce the number of inspections it can conduct, said the office’s Associate Commissioner for Regulatory Affairs Michael Rogers during an Alliance for a Stronger FDA webinar Wednesday. Read More
A recent Warning Letter to www.dashpct.com, a Malaysian online marketer, should send a clear message that the agency is getting tough on companies selling unapproved and misbranded semaglutide (Rybelsus/Ozempic/Wegovy). Read More
In a punishing one-two punch, the FDA slammed Zydus Lifesciences for the second time this month, with a 10-observation Form 483 finding — among other things — inadequately investigated glass particulate in injected drugs found in US markets and multiple deceptions about routine sample collection for contamination testing. Read More
Three Eugia Pharma plants in India have received Form 483s following inspections conducted in the last two months, all laden with examples of the company failing to follow procedures to prevent microbiological contamination of its drug products, among other lapses. Read More
Holes in the roof, potential mold on and around air vents, and an employee’s garment extensively touching filling apparatus are among the observations listed in the FDA’s Form 483 levied on India-based generic pharma Zydus Lifesciences. Read More
Cipla, the third largest pharmaceutical company in India, received a Form 483 after an FDA inspection March 28-April 4 reported failures in cleaning and maintenance to prevent contamination as well as failures to investigate out of specification product. Read More
A drug manufacturing facility with ungowned, barefoot employees received an FDA Warning Letter that cited “insanitary conditions” in the production of sterile ophthalmic drug products, and was among the manufacturers cited in a recent FDA consumer warning on the risk of contaminated eye drops. Read More