CMOs fall foul of FDA regulations
San Diego-based PrimaPharm has been warned by the FDA for not adhering to procedures to prevent microbial contamination of sterile pharmaceuticals, and also for manufacturing unapproved and misbranded drugs.
The company also failed to investigate batch failures and to see whether the problems extend to other batches, and to set up effective systems for environmental monitoring and cleaning and disinfecting production areas, according to the FDA.
“These deviations raise significant concerns with sterility assurance of products that were produced under these conditions,” said the agency in a letter to PrimaPharm chief executive Charles Shuster.
In addition to making products for other companies, PrimaPharm sells a range of herbal and homeopathic remedies under the PrimaVu brand.
Connecticut-based Contract Medical Manufacturing has also been taken to task for its sterile manufacturing practices by the FDA. The company makes sterile custom cranial implants designed to correct injuries to the head, face and jaw.
In a letter to managing partner Patrick Brandon and partner Richard Deslauriers, the agency says the firm has not verified and validated its production processes, including sterilisation and packaging of devices.
The violations “may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems,” according to the letter.
Meanwhile, the FDA has issued a class 1 recall for Stryker Custom Cranial Implant Kits, manufactured by Stryker Leibinger USA, because of lack of assurance of sterility and risk for infection, according to an alert sent on December 24 from MedWatch.
Class 1 recalls warn of situations in which there is a reasonable probability that use of the recalled products will cause serious injury or death.