Repacker Receives Warning Letter


In a recently posted warning letter to a repackaging, relabeling, and own label distribution facility several violations of cGMPs were identified.

The firm failed to validate the cleaning process uses for non-dedicated pieces of equipment used to repackage drugs such as steroids, anticonvulsants, statins, and antidepressants.  There is no assurance that the cleaning processes are adequate to prevent unacceptable levels of residual product and cleaner on product contact surfaces for this equipment.

The firm assigned expiration dates using either the manufacturers’ expiration date or a date of 1-year from the date of repackaging with no stability testing.  FDA CPG 480.200 states the expiration date of a repackaged drug should not exceed 6 months.

The firm’s quality unit failed to review production batch records prior to release (noted in 42 of the 104 batch records reviewed by FDA).

The firm had no validation for the filling and sealing processing equipment that was used in the repackaging of 74 different drug products into dose containers.

Noted in the warning letter, the observations from the 2015 inspection are similar to those identified in 2013, and the response letter to FDA the firm promises the same corrective actions that were in the response to the 2013 inspection.  To help ensure progress toward correcting the cGMP violations, the FDA has requested quarterly updates of sufficient detail such that the FDA can independently assess progress.