Epimed International Inc. was cited in a Form 483 for inadequate procedures for handling of complaints, design validation, design transfer, control over products, services and suppliers, and accepting incoming products at its Johnstown, N.Y. facility.
The FDA cited the manufacturer of pain management, radio frequency and cryoanalgesia products for five observations.
The inspector’s first observation found that the company failed to adequately establish procedures for receiving, reviewing and evaluating complaints by a formally designated unit.
The 483 also cites Epimed for not adequately establishing procedures for design validation and design transfer. For example, the validation of a catheter was approved without a missing data point regarding catheter removal being identified or corrected, and the design validation did not follow the firm’s procedures.
The inspector also found that the type and extent of control to be exercised over the firm’s products, services, and suppliers were not clearly defined.
Specifically, the supplier of Epimed’s bulk non-sterile RK epidural needles changed production to a new site and new contract manufacturer. However, Epimed had no documentation showing approval of this change and did not define the extent of control it had over the supplier.
Finally, the inspector found that the company had not established adequate procedures for accepting incoming products, including epidural needles.
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