If you have any doubts of the FDA's sincerity in its promises of speedier interactions with drugmakers and transparent communication with the public, just ask Braintree Labs. The drugmaker has seen the public posting of a follow-up warning letter regarding manufacturing deficiencies just a scant nine days after the date on the letter itself.
The warning letter follows company responses of February 10 and March 19, 2010, to the initial warning letter, issued after an inspection that ended in late January. That is more than speedy in GMP-violation warning time.
Most egregious of the manufacturing transgressions, from a consumer point of view, are the presence of spiders, insects and insect parts in the laxative. Some 21 consumers complained but the company concluded the foreign material could not be attributed to its manufacturing practices. The FDA says in the letter, however, that Braintree conducted no investigation into whether facility or raw material quality problems were at fault.
"Your responses are inadequate," the letter states. It cites the company's February response, in which Braintree states that the foreign matter presents no inherent health hazard. "FDA considers contamination of finished drug products with foreign material (e.g., insects) a significant product quality issue," the warning letter continues.
The FDA also questions the company's "fundamental understanding of the regulatory expectations and requirements when conducting out-of-specification investigations," and references available guidance.
- here's Warning Letter NWE-17-10W
Editor's Note: Yesterday's item about Braintree Labs' second FDA warning letter incorrectly identifies the contaminated product as Miralax. Merck tells us that Braintree Labs ceased manufacturing Miralax in August 2009, when Merck moved manufacturing to its own facilities. The move preceded the FDA inspection of Braintree Labs, which led to the warning letter. The warning applies in no way to Merck manufacturing operations, and has no effect on the drugmaker's ability to continue supplying Miralax. We regret the error.