FDA 483 - Aptuit Ltd - May 15, 2009

The FDA inspection identified several deficiencies in the facility's quality system and manufacturing processes. Rework and reevaluation activities were not fully documented in device history records, as seen with an S3 custom bed (Order # (b) (4), Serial # (b) (4), 3/20/2009) where initial load cell calibration failure was not documented, only the passing rework results. An investigation into missing bolts and washers on Electric Stretcher (catalog # 1550000000, complaint PER (b) (4), 12/30/2008) failed to evaluate units manufactured before a procedural instruction change on 2/17/09.

Procedures for monitoring and control of process parameters for validated processes were not implemented; specifically, a revalidation procedure for Castor Mount W (b) (4) (02/05/2009) pulled (b) (4) samples, but only (b) (4) were tested for pass/failure. Changes to methods were not implemented, as evidenced by CAPA (b) (4) regarding a vendor change to Brake Plate (3006-200-356) in August 2008, with no documented review or disposition of existing inventory or inspection to ensure correct stamping.

An MDR report was not submitted within 30 days for complaint PER#