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AMO Puerto Rico Investigations Lacked Root Cause, 483 Says

November 12, 2010
AMO Puerto Rico Manufacturing’s investigations of consumer complaints do not always include a root cause determination, according to a recent Form 483.

The company’s investigation of some complaints consisted solely of a review of the device history records, the form adds. In such cases, AMO based its assessment on a review of the executed manufacturing records.

Additionally, not all consumer complaints for products manufactured at the Anasco, Puerto Rico, site were fully and uniformly reviewed and investigated to identify all corrective and preventive actions, the form says.
The GMP Letter