The FDA rapped Maitland Engineering for numerous deficiencies including a lack of validation for testing, inadequate process controls and protocols for rework of nonconforming product.
The agency issued a Form 483 after a September 2017 inspection of the company’s South Bend, Indiana facility. Investigators observed problems with one of the facility’s cleaning processes that did not meet the company’s own definition of operational qualification, failing to identify all operating parameters, operation ranges or acceptance criteria.
The firm’s process for cleaner validation also did not include a performance qualification section as required under Maitland’s process validation SOP, according to the FDA.
The agency also found Maitland’s process control procedures for a device component featured conflicting requirements for cleaning the device, with different documents disagreeing on whether there was a cleaning process prior to certain steps in the production process.
The investigator also flagged the company’s procedures for rework of nonconforming product. Of 11 nonconformity reports the agency reviewed, one re-inspection did not include all aspects of the device that might have been affected during the rework operation.
In addition, the inspection found problems with Maitland’s corrective and preventive action procedures. The firm’s corrective action SOP called for all reviews to include verification and validation of corrective actions that involved follow-up actions.
However, in 4 of 11 CAPAs reviewed during the inspection, the “verification” performed by the firm only documented the implementation of the corrective action and did not assess whether or not the corrective action was effective.
Read the Form 483 here: www.fdanews.com/03-23-18-maitlandengineeringinc483.pdf. — Zack Budryk