The FDA has nailed an Australian contract manufacturer with a warning letter for serious manufacturing and quality lapses after banning the company’s products in the fall.
The warning letter was sent late last month to Delta Laboratories of New South Wales, Australia, after the FDA put all of the company’s human and animal drugs and antibiotics on its import alerts list in September.
According to the FDA, Delta didn’t fully investigate discrepancies, including signs that might have indicated microbial contamination and didn’t have the processes needed to assure products would remain stable during storage and through the expiration date. It also noted the quality assurance unit didn’t have the necessary authority to make sure those kinds of standards are met.
In one instance, the FDA said that the company found tubes swelling at the three-month stability time point but didn’t investigate “this significant defect,” which the agency said might indicate “microbial growth and spoilage.” After the FDA noted the issue, Delta in late November recalled the remaining units in the U.S.
A batch was released even though stability testing found issues with appearance and viscosity, the warning letter says, according to the FDA.
“Senior management stated that your firm has struggled with manufacturing this drug product, and that you were still conducting research to gain better product and process understanding. Although you acknowledged a lack of understanding to assure consistent quality, you still commercially distributed drug products to consumers,” the FDA pointed out to the firm.
The agency strongly recommended that Delta hire a consultant if intends to continue to producing products for the U.S.