CGMP Deviations at Fenwal International

A 9/16-9/26 FDA inspection at Fenwal International, Maricao, Puerto Rico, found deviations from current good manufacturing practice requirements for the manufacture of the firm’s blood-pack units with and without in-line leukoreduction filters, as well as InterSol, a platelet additive solution. A just-released 5/14 Warning Letter says the company microbiology laboratory did not accurately document test results.

The letter acknowledges corrective actions Fenwal represents to have taken and expresses FDA’s concerns about the adequacy of the corrective actions to date.

FDA says the deviations indicate that the company’s quality control unit is not fulfilling its responsibility to assure the identity, strength, quality, and purity of its drug products.

Fenwal was told to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with documentation for each step and a schedule for completion.