FDA warns Braintree Laboratories about bugs in its laxatives
|
|
  |
The Food and Drug Administration has issued a second warning to Braintree Laboratories after insects were discovered in some of its products.
The FDA received 21 complaints from consumers who found insects, insect parts and spiders in five products made by the Braintree-based company at its Holbrook manufacturing facility, according to a May 10 letter to the company from John R. Marzilli, district director for the New England District of the FDA in Stoneham.
FDA investigations in December and January identified significant violations of Current Good Manufacturing Practice regulations at the pharmaceutical company, which makes gastrointestional drugs including the laxative MiraLax.
Braintree Laboratories failed to determine if “facility or raw material quality problems were at the root of these complaints,” Marzilli wrote.
The company previously told the FDA it would increase pest control monitoring, look for trends among complaints and determine the origin of the insects.
But, the FDA also wants Braintree Laboratories to submit a plan for determining additional potential contamination sources and audit its raw materials and packaging suppliers.
“FDA considers contamination of finished drug products with foreign material (e.g., insects) a significant product quality issue,” Marzilli wrote.
Officials from Braintree Laboratories were unavailable for comment Wednesday, a company operator said.
The company has 15 working days upon receipt of the letter to tell the FDA what they are doing to correct the violations or seek an extension. If they fail to act, Braintree Laboratories could face product seizure, injunctions, or withholding of future product approval requests.
FDA officials examine each situation on a case-by-case basis to determine what penalties are imposed, said Mary Yebba, public affairs specialist for the FDA’s New England District.
Brian Benson may be reached at bbenson@ledger.com.
