The FDA cited Caliber Imaging and Diagnostics over its device software validation, CAPA procedures and design verification.
The agency hit the medical device manufacturer with a Form 483 after a May/June inspection of its Rochester, NY, facility. Investigators found the software validation for an update to one of its products, signed off in September 2016, left multiple sections blank or crossed out with no justification. In the case of some tests that were noted to have failed, the facility did not maintain a record or defect report, the agency said.
The FDA also took issue with the software used during production, noting the company’s documentation did not include procedures for validation.
Investigators reviewed 12 CAPA records and found several were not verified or validated as effective. In addition, a revision to the company’s CAPA procedures did not include a requirement to validate or verify CAPAs to ensure there were no adverse effects.