FDA hits Clinicon with warning letter over sterility failings

Dive Brief:

FDA has issued a warning letter to Oceanside, California-based medtech Clinicon after discovering quality failings at a facility that makes devices including SureProbe sterile, single-use laser accessory probes.
The inspectors found fault with the validation and calibration of processes and equipment involved in ensuring sterility of the SureProbe devices.
Clinicon, which FDA said failed to address its concerns in its Form 483 response, now has 15 days to detail the steps it plans to take to address the quality problems.

Dive Insight:

In April, FDA inspectors visited the California facility where Clinicon makes SureProbe devices for use in the incision, ablation and cauterization of soft tissue. The inspectors identified multiple aspects of the operation that were noncompliant with FDA rules on good manufacturing practices and quality systems, leading to a Form 483 and ultimately a warning letter.

The first point made in the warning letter is that Clinicon failed to provide validation documentation for the SureProbe packaging process during the inspection. Clinicon’s contract sterilizer validated the devices in 2015, three years after the company started selling them, but FDA found no evidence of prior or subsequent validations. The validation report states periodic requalification is required.

FDA also took issue with other aspects of Clinicon’s packaging and sterilization operation. When asked to provide documentation showing process validation was done for sterile product package sealing, Clinicon provided FDA with a sealing procedure from 2011.

“You told our investigator that no package integrity testing has been performed and you could not provide evidence to show how the packaging procedure was developed per a protocol with pre-approved acceptance criteria, test data or any final report to validate the sealing process can maintain sterility barrier,” FDA wrote in the warning letter.

The inspectors criticized Clinicon’s failure to calibrate the pneumatic heat sealer used to create the sterile barrier for the SureProbe products. In explaining the situation, Clinicon said the employee who handled many quality functions left around one year ago and that since then the company has struggled to locate documents.

FDA initially set out these concerns in a Form 483. Clinicon responded with a letter stating it would send another response within 90 days. However, as the initial response lacked additional information or supporting documentation of corrections FDA deemed it to be inadequate and warranted the warning letter.