Devices

9 QS Violations in CellEra Inspection

David McFarland

— 1 min read
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A 6/16-7/8 FDA inspection at CellEra, a Monroe, OH, specification developer and own-label distributor of various sterile wound dressings with drug, identified nine Quality System Regulation violations, including seven repeat violations from an earlier inspection. A 10/20 Warning Letter says the specific violations were: 

  •          failing to establish and maintain procedures for implementing corrective and preventive actions and failing to document corrective and preventive actions;
  •          failing to establish and maintain procedures to control the design of the device;
  •          failing to establish and maintain procedures for identifying, documenting, validating or, where appropriate, verifying, reviewing, and approving design changes before their implementation;
  •          failing to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements;
  •          failing to establish and maintain procedures for accepting incoming products that should be inspected, tested, or otherwise verified as conforming to specified requirements;
  •          failing to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
  •          failing to establish and maintain procedures to control all documents;
  •          failing to establish and maintain procedures to adequately control environmental conditions, where environmental conditions could reasonably be expected to adversely affect product quality; and
  •          failing to develop, maintain, and implement written Medical Device Reporting procedures. 

The letter says the company’s responses to all the inspection observations were inadequate. FDA says the specific violations noted in the letter and the FDA-483 issued at the end of the inspection “may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations and take prompt actions to correct the violations and bring the products into compliance.”

CellEra was told to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of the corrections and corrective actions and a timetable for implementation.

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