The FDA issued a warning letter to Pharmasol over violations at two of its drug manufacturing facilities, including problems with quality oversight and leaky stability samples.
The agency’s July to August 2018 inspection of the contract manufacturing organizations’ South Easton and Stoughton facilities found significant lapses in CGMP and several repeat observations.
The South Easton facility—which the FDA flagged for similar observations in 2013, 2014 and 2015 inspections—failed to adequately address leaking stability units prior to product release in 2017. Although Pharmasol adopted a new container-closure system, the agency found that stability samples were still leaking, and four complaints of leakage were classified as “unconfirmed.” Stability studies for a separate product also found a loss of container-closure integrity.
“Drug products lacking an integral container-closure system may lose efficacy due to loss of solvent, degrade due to exposure to oxygen, fail to meet potency specifications, or suffer from microbial contamination,” the agency said.