The FDA hit California-based pharma company United Exchange Corp. with a warning letter, citing the company for a number of “significant” violations with its quality-control systems both in-house and with contract manufacturers.
The regulatory agency inspected the company’s two operations in California in early April last year. United Exchange also has a warehouse in Mississippi. According to its website, United Exchange delivers private label, control and licensed health, personal care, beauty, pet and consumer goods to “food, drug, dollar, club and mass retailers throughout the world.”
In its warning, the FDA said the company’s quality unit “failed to institute adequate oversight and controls” over its contract manufacturers. The lapse led to “your use of multiple substandard contract manufacturers.” The agency added that since 2016 it has taken a number of actions related to good manufacturing practices violations found a United Exchanges’ CDMOs, though it did not name the CDMO.
United Exchange was also cited for failing to set adequate procedures for the receipt, examination and storage of incoming drug products. The agency said one of its investigators found quarantined drug products stored in the same area as released drug products.
“Your firm lacks suitable quarantine controls to distinguish quarantined drug products from released finished drug products,” the FDA said.
The agency gave the company 15 working days to respond to the warning letter and recommended it hire a CGMP consultant as well as more quality unit personnel.