Alexion Pharmaceuticals, Inc. — FDA 483 Findings

Tbe Quality Unit has not ensured verification ofwhether current sampling procedures for larger drummed raw materials could potentially contaminate the room in which they are sampled or other raw materials.

The firm's investigations into Soliri- microbiological contamination events are inadequate.

Fo llowing a confirmed Bacillus thuringtensis contamination in biore actor redacted (b)(4) for Soliris lot redacted (b)(4) on July 18, 2012, the decontamination of bioreactor redacted (b)(4) was executed, followed by a routine CIP cycle.

Deviations are not required to be initiated for all visual inspection failures, for example post CIP visual inspection fa ilures.

Following a confirmed Bacillus thuringiensis contamination in bioreactors reda cted (b)(4) and redacted (b)(4) for Soliris lot redacted (b)(4) on January 14, 2012, a routine CIP cycle was executed for redacted (b)(4) on January 18, 2012.

The procedure "Quality Control of Microbiological Media" SOP QC-0201, version 5.0 is used for growth promotion of redacted (b)(4) used in the environmental moni toring program.

Deviation 3324 was initiated due to a leak on the interior of the drywall in a column in the cell culture area redact ed (b)(4) A tent was constructed prior to cutting into the drywall to investigate the leak which was observed t o have caused mold on the column drywall interior.