L. Perrigo Co — FDA 483 Findings

Written procedures describing the handling of complaints do not include provisions for review by the quality control unit o f any complaint involving the possible failure of a drug product to meet any of its specifications and a determination as to th e need for an investigation of any unexplained discrepancy .

Procedures describing the handling of wri tten and oral complaints related to drug products are deficiently wri tten or followed.

The w ritten record did not include the reason an investigation was found not to be necessa ry and name of the responsible person making the determination not to conduct an investigation when an investigation into unexplained discrepancies wa s not conducted.

Investigations of an unexplained discrepancy did not extend to other drug products that may have been associated with th e specific failure or discrepancy .

Complaint procedures are defi cient in that written complaint files are not maintained at the manufacturing site nor were the y readily available from their off-site location .

Complaint records are deficient in that they do not document the reason and the individual making the decision not t o conduct a complaint investigation .

Complaint records are deficient in that they do not include the known reply to complainant .