FDA Cites Ohio Devicemaker for Arrangements With CMOs

The FDA hit Monroe, Ohio device manufacturer CellEra with a Form 483, calling the firm out for lacking proper arrangements with contract manufacturers.

An inspection by the agency revealed that the firm lacked a purchasing controls procedure, quality requirements, documented evaluations or purchasing agreements with its CMOs.

The facility also lacked adequate procedures for acceptance activities, including for inspection, testing or verification of incoming finished product.