FDA 483 - Corden Pharma Boulder, Inc. - June 21, 2011

This FDA Form 483 documents observations from an inspection, highlighting significant deficiencies in manufacturing processes and quality control. The firm released numerous Carboplatin batches (e.g., A-3809-09-0011R, A-3800-10-0001, A-3800-11-0001) without a validated manufacturing process. Several of these batches (e.g., A-3800-11-0001, A-3800-10-0005R1) were also released without being placed on a stability testing schedule.

A concurrent validation process for Carboplatin Batch #A-3800-11-0008 showed nineteen redline changes to the batch record, deviating from the approved validation protocol. Equipment and utensils were not cleaned at appropriate intervals, as evidenced by white powder residue on an isolator glove attachment rim observed on June 14, 2011. The relevant SOP (A-MPE-0058 Rev. 11) was deficient, lacking instructions for cleaning these metal rims.

Written procedures for equipment cleaning were inadequate, specifically for equipment used interchangeably between active pharmaceutical ingredients like Carboplatin, Paclitaxel, Trovafloxacin, and Pamidronic Acid. The cleaning batch record AA050 Rev.