FDA sends Mylan Puerto Rico plant a GMP warning letter
A US Food and Drug Administration (FDA) inspection of the Caguas, Puerto Rico plant at the start of 2011 found uniformity testing and batch failure investigation failings. Mylan replied in March but failed to satisfy the FDA and seven months later the agency sent a warning letter.
“Your firm does not have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product prior to release”, the FDA wrote.
The FDA cites failure to complete a content uniformity test required by the US Pharmacopeia (USP). A batch of loperamide hydrochloride capsules, a diarrhoea treatment and only drug named in the letter, failed to conform to the acceptance criteria of the USP test.
Investigators also questioned Mylan’s procedures when batches failed to meet specifications. The FDA said Mylan attributed out-of-specification results to assignable causes but failed to provide enough evidence to invalidate the original data.
The impact on Mylan
Mylan first built a plant in Puerto Rico in the 1980s as it expanded sales in North America. In a video titled ‘How Mylan Drugs are Made’ the generic company highlights “the large scale potent-substance operations” at the 140,000 sq ft Caguas’ site.
Shares in Mylan closed up 1.3 per cent after plunging at the start of the day. Investors may have been reassured by an analyst report that Mylan has no imminent product approvals reliant on the plant. Also, the FDA only raised two problems and the plant is a relatively small part of Mylan’s operations.
Puerto Rico in 2011
In 2011 Puerto Rico has faced a succession of questions about the quality of manufacturing on the island. The year began with 60 Minutes looking at quality problems at GlaxoSmithKline’s Cidra, Puerto Rico plant.
Since then: Bristol-Myers Squibb has recalled 64m pills manufactured in Puerto Rico; a US Congressman has said FDA oversight of the island is “deeply troubling”; and a research paper has claimed offshore knowledge transfer may cause quality problems.