By Jim Dickinson
An FDA inspection at Carousel Solutions (dba Xtract Solutions) in Portland, OR, has found quality system regulation (QSR) violations in the firm’s work as a specification developer of the Syringe Key and ER-SHOT devices.
An August 8 warning letter from the agency’s Seattle District Office says that specific violations noted on an FDA-483 in April included:
- Failing to establish and maintain procedures to ensure that the design requirements relating to a device are appropriate.
- Failing to establish and maintain procedures for verifying the device design.
- Failing to establish and maintain procedures to validate the device design.
- Failing to establish procedures to ensure that the device design is correctly translated into product specifications.
- Failing to establish and maintain procedures to control all documents.
- Failing to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements.
- Failing to establish procedures to ensure that sampling methods are adequate for their intended use, and written and based on valid statistical rationale.
- Failing to conduct quality audits to assure that the quality system complies with the established quality system requirements and to determine quality system effectiveness.
The company was told to take prompt action to correct the violations and to respond with a list of specific steps taken, documentation of each step, and a timetable for completion.
Jim Dickinson is MD+DI's contributing editor.
[image courtesy of KIBSRI/FREEDIGITALPHOTOS.NET]