In a brief statement posted on its website, Bristol said it had been informed by the FDA that the corrective actions it had taken at its Manatí manufacturing facility “have sufficiently addressed violations raised in the 2010 FDA Warning letter to the company regarding that site.”
That lengthy letter was issued in August 2010, when the agency’s San Juan office told Bristol executives that it was concerned over the quality of the drug products being manufactured in its aseptic operations in Manatí.
At the time, the FDA said “your firm has not established or followed appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile.”
Apparently, the FDA had issued a similar warning to Bristol as a result of plant inspections in 2005 and 2009.
“Bristol-Myers Squibb remains committed to ensuring the actions it has taken at the Manati site are maintained and that the site is in compliance with both company and regulatory requirements,” the company said in the statement.