According to a Form 483, Protech Professional Products did not establish procedures for design control, corrective and preventive actions, and control of non-conforming products at one of its facilities.

A visit to the company’s Boynton Beach, Fla., facility produced several observations, including that the facility did not have a procedure for design controls that included provisions for inputs, outputs, reviews, verification, validation, transfer, and changes. In addition, documents provided to inspectors as part of a product’s design history file did not include several of these categories. The observation repeated a deficiency in a warning letter in July 2014.

Inspectors also observed that procedures for corrective and preventive actions were not established. For example, a CAPA procedure did not include requirements for investigating and determining the root cause of non-conformity, and seven of 11 documented CAPA actions lacked such a determination.