Chinese, Canadian Drugmakers Receive FDA Warning Letters
Posted 12 September 2018 | By
The US Food and Drug Administration (FDA) on Tuesday released two warning letters sent to China-based Longood Medicine (Beijing) Co., Ltd. and Quebec-based Lernapharm Inc.
For Lernapharm, which manufactures safety lancets, FDA raised a number of questions about the firm’s sterility for products labeled sterile.
FDA found the firm reprocessed multiple batches of certain drug products purporting to be sterile, but which “did not meet process parameters or quality attributes. In one instance, you reprocessed [redacted] after five biological indicator (BI) strips were found with microbial growth.”
The agency also said Lernapharm failed to investigate customer complaints about leaking seals and debris in the sealing, among other issues. Lernapharm confirmed that it received the warning letter and that it intends to respond in a timely manner and work closely with FDA to adddress any concerns.
And for China-based Longood, FDA called out the firm’s struggles in overseeing its contractors, noting that it failed to ensure a contractor used a validated terminal sterilization process consistent with certain US requirements.
“You released Chlora-Cleanze Proprep applicators without assurance of their sterility,” FDA said.
FDA investigators also found “numerous uncontrolled and unofficial production and laboratory records” linked to Chlora-Cleanze Proprep applicators, and the agency said the firm did not perform a retrospective review to determine the full extent of the production and laboratory record deficiencies.
Longood Medicine (Beijing) Co Ltd 8/27/18
Lernapharm (Loris) Inc. 9/4/18
Article updated on 9/12/18 with Lernapharm comment.