- The Food and Drug Administration has issued a warning letter to a Florida drug manufacturing plant owned by a Teva Pharmaceutical subsidiary, flagging several violations of Good Manufacturing Practice that have persisted through multiple inspections across the past five years.
- The letter, which was issued to an Actavis Laboratories site in Davie, Florida, cites problems with production and process control, which the FDA notes could undermine monitoring for consistent drug quality. The FDA's citation also points out that Actavis failed to fully investigate drug product failures.
- In previous responses to the FDA, Actavis claimed it retained services of third-party consultants. The regulator's letter, however, reminds the drugmaker that the company's management remains ultimately responsible for GMP compliance.
The warning letter from the FDA shouldn't come as a surprise to Teva investors. Company CEO Kåre Schultz alluded in a recent earnings call to the scrutiny faced by Teva as a result of FDA inspections.
"We have had an inspection last year in a site in Florida – Davie – where we recently got a warning letter, which was expected," Schultz said on the February call. "We're working to rectify it. And we don't see it having any short-term negative effect on our business."
While Schultz said that the company strives for "perfect compliance and quality," the manufacturing issues at the Florida site have persisted even after Teva acquired Actavis from Allergan in 2015. The warning letter notes that past inspections in December 2013, January 2016 and November 2017 picked up similar issues.
While Actavis has proposed specific remediation for the FDA's observations, the FDA appears to have lost patience with the plant's progress in fixing its issues.
"These repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate," the letter stated.
Teva's acquisition of Actavis burdened the Israeli drugmaker with a sprawling manufacturing network just as the market for generics tightened considerably.
Teva cut its expenses by $2.2 billion in 2018 and looks to trim another $3 billion this year.