Indianapolis, Indiana-based specialty pharma firm AFP was visited by US Food and Drug Administration (FDA) inspectors in June 2014 who identified a number of significant violations of current good manufacturing practice (cGMP) at the site, resulting in a Warning Letter issued in July but published yesterday.
Among the violations, the Agency said the firm gave numerous batches of aspirin tablets produced over five months the same lot number (12084), negating the ability to differentiate between lots. These were distributed with no review from the firm’s quality unit to ensure the identity, strength, quality, and purity of the products, the Letter said.
“FDA also found that the lot 12084 tablet colour was inconsistent. Tablets were different shades of yellow,” the Agency continued. “According to Form FDA 483, Observation 5, your firm received at least four customer complaints about inconsistently coloured tablets. You received these complaints from January to May, 2014. You did not investigate them.”
Blending uniformity issues
The firm was also picked up on failing to establish tested procedures for identity and blend uniformity testing, and failing to evaluate whether active blends used repeatedly over extended periods remained of acceptable quality throughout their use period.
“Blend segregation problems and moisture uptake are among the problems that can occur during these long use periods and can lead to significant issues with tablet compression,” the FDA said. Furthermore, “your procedures for compressing tablets and operating the tablet press do not require in-process sampling for parameters such as tablet weight variation, hardness, and friability.”
According to the letter, AFP ceased all operations in May 2014 but said it would resume operations when it acquired necessary funds.
“FDA strongly recommends that if you decide to resume production, you undertake a comprehensive assessment of your operations before you restart manufacturing and distributing any drug products.”