FDA 483 - leiter's cambrian park drugs, inc., - March 06, 2014

The FDA inspection revealed significant deficiencies in the manufacturing and quality control of Brilliant Blue G D2O 0.025% and other sterile drug products. The firm failed to ensure sterility and pyrogen-free status through adequate testing. Sterility testing by a contract lab lacked method suitability data and did not meet USP <71> requirements for sampling/method suitability. No endotoxin release specification was established, and products were released regardless of endotoxin results.

Aseptic process validation was inadequate. One operator for the Baxa Repeater Pump, used for Brilliant Blue G D2O 0.025%, was not qualified per SOP. Media fill records lacked documentation of the hood used and the number of operators present. Environmental monitoring procedures were not followed, with surface and fingertip samples not taken on multiple dates due to lack of supplies, even when Brilliant Blue G D2O 0.025% was filled. Personnel were observed with makeup in the cleanroom, violating garb SOPs.

The firm used expired raw material (Sodium Phosphate Monobasic Monohydrate) for six lots of Brilliant Blue G D2O 0.025% and failed to conduct a comprehensive investigation into its impact. Finished product potency testing was never performed for 14 lots of Brilliant Blue G D2O 0.025%. There was no stability testing program to justify the 180-day Beyond Use Date for Brilliant Blue G D