FDA 483 - E-Beam Services, Inc. - January 27, 2020

An FDA inspection of E-Beam Services, Inc. in Cranbury, NJ, a sterilizer facility, revealed significant deficiencies in equipment maintenance documentation and adherence to calibration procedures. The firm failed to log repairs and associated activities for non-conformances related to their E-Beam sterilizer and did not follow established procedures for line speed calibration, without documenting any rationale for the deviation. These findings indicate a lack of control over critical equipment processes.