Quality violations at Tedor Pharma’s Cumberland, Rhode Island site netted the drugmaker a Form 483 from the FDA for inadequate testing, cleaning and calibration procedures.
During a Jan. 14-31 inspection, the FDA investigator found deficient cleaning and testing processes for multi-use production equipment. Specifically, the equipment wasn’t properly evaluated for bacteria on the surface. The agency also cited the facility for equipment calibration procedures.
In addition, the firm failed to conduct studies to determine if construction materials for a distribution loop and holding tank had an effect on water quality over time.
The agency also noted that certain records relating to drug production were not made available for evaluation during the inspection; the firm couldn’t track down an original installation and operational qualification used in the manufacturing of certain exhibit batches.