EMS Inc. – FDA EIR, Mar 4, 2011

An FDA surveillance inspection was conducted at Bioanalytical Systems Inc., BASi Northwest Laboratory (BASi NWL) from February 28 to March 4, 2011. The inspection, operating under the Good Laboratory Practice program (CP 7348.808), aimed to assess compliance with regulations governing nonclinical laboratories and the Food, Drug, and Cosmetic Act. The facility operates as a contract research organization providing bioanalytical services. Key violations documented in an FDA Form 483 included the inability to verify the identity of freeze-thaw stability samples, insufficient demonstration of incurred sample reproducibility, failure to follow written procedures for special handling of reference samples, and the presence of expired reference standard materials in active storage areas. Additionally, the company lacked written procedures for investigating pipette malfunctions during operations. Discussions also highlighted the absence of written controls for alternate equipment identification, inadequate investigation protocols for time-dependent excursions, incomplete method descriptions for stock solution preparation, and undefined criteria for dilution factors in incurred sample reproducibility. BASi NWL management initiated voluntary corrections during the inspection, offered clarifications regarding the identified deficiencies, and committed to further remedial actions. The General Manager stated an intent to provide a written response to the FDA Form 483 within fifteen days. The Agency emphasized the company's ongoing responsibility to maintain full compliance.