483
ORTHO PRECISION PRODUCTSFDA 483 - ORTHO PRECISION PRODUCTS - November 14, 2023
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Record Details
An FDA inspection of ORTHO PRECISION PRODUCTS in Hawthorne, CA, from November 7-14, 2023, identified one observation related to inadequate maintenance of device history records. Specifically, several work orders were found to be missing critical in-process inspection results, dates, and initials. These issues were not addressed prior to lot release, despite internal quality work instructions.
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ID · b7296390-6725-4440-a07b-137e67001212