Medical Device Link.

WASHINGTON WRAP-UP

FDA’s warning letter to Wallach Surgical Devices listed the following violations:

• Failure to validate with a high degree of assurance a process whose results cannot be fully verified by a subsequent inspection and test.
• Failure to ensure that each lot of finished devices meets acceptance criteria prior to final distribution release.
• Failure to establish and maintain procedures to ensure that all received product conforms to specified requirements.
• Failure to establish management controls to ensure that an effective quality system has been established and maintained.