Consultants Specializing in Regulatory Affairs for FDA Compliance

Recalls

The most common observation when Smith Associates has audited companies is errors that occur with incoming component acceptance criteria and finished product acceptance. If discrepancies should occur in either, even if the product is 2 or 3 years old, recalls can and probably will be ordered by the FDA. Recalls can be ordered by the FDA even if there is not a single complaint with the device, if that device has failed its final acceptance. Recalls may result from your 483 Observations or from a Warning Letter. Like all responses to the FDA, a Recall must be comprehensive and exhaustive in removing all recalled product from distribution. Smith Associates can provide the assistance in contacting your distribution or hospital network.

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