FDA 483 - Psoria Shield, Inc. - September 14, 2023

Psoria Shield, Inc. was subject to an FDA inspection from September 11-14, 2023, resulting in a Form FDA 483 outlining four significant observations related to its quality system. These observations indicate a need for the company to enhance its compliance with regulatory expectations for medical device manufacturers.

The main issues identified included a lack of established or properly followed procedures for equipment calibration and maintenance. A key piece of equipment used for critical energy/power output tests on finished device hand pieces was found to be significantly overdue for calibration since March 2021, despite internal procedures stating such equipment should not be used.

Additionally, the company's procedures for ensuring purchased products and services conform to specified quality requirements were deemed inadequate. Supplier evaluation processes lacked essential details regarding expected component quality, and there was no requirement for suppliers to notify the firm of relevant changes.

The FDA also noted deficiencies in the firm's complaint handling system, specifically the absence of standardized procedures for receiving, reviewing, and evaluating complaints, including determining Medical Device Report (MDR) reportability. A review of eight complaints showed no assessment for MDR reportability.

Finally, Psoria Shield's corrective and preventive action (CAPA) procedures were found to be insufficient, lacking provisions for verifying or validating the effectiveness of implemented actions. Ten out of twelve reviewed CAPAs did not include documentation of effectiveness checks.

As a result, Psoria Shield, Inc. is required to address these inspectional observations by implementing robust corrective actions to ensure full compliance with quality system regulations.