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# Legacy Pharmaceutical Packaging FDA-483
- URL: https://www.fdaweb.com/legacy-pharmaceutical-packaging-fda-483/
- Published: 2021-01-04T12:00:00.000Z
- Updated: 2026-09-14T16:40:55.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148367

FDA has just released the FDA-483 with five observations issued following a 1/13-1/16/20 inspection at Legacy Pharmaceutical Packaging, an Earth City, MO, medical device contract manufacturer. The observations were: 

- failing to adequately validate according to established procedures a process whose results cannot be fully verified by subsequent inspection and test;
- failing to document in the device history record rework and reevaluation activities;
- failing to adequately establish procedures to control product that does not conform to specified requirements;
- failing to adequately establish schedules for the adjustment, cleaning, and other maintenance of equipment; and
- failing to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.