FDA 483 - Legacy Pharmaceutical Packaging LLC - January 16, 2020

This FDA Form 483 details observations from an inspection, primarily concerning the validation and control of a packaging vision system. The facility failed to adequately validate a process whose results cannot be fully verified by subsequent inspection and test.

Specifically, the Performance Qualification (PQ) for Packaging, dated 12/23/19, was deficient. The vision system's Optical Character Recognition (OCR) capability, critical for detecting incorrect part codes or UDI barcodes, was never challenged during PQ lots, despite being a critical quality classification. Challenges for missing/illegible codes used uncontrolled test articles.

Furthermore, the final PQ report omitted critical events: maintenance performed on the vision system during PQ lot (b) (4) due to excessive rejections was undocumented, and the number of labeling rejects (nonconformances), a critical quality attribute, was not recorded or evaluated. Rework of rejected/mislabeled cartons during PQ lots was also not documented or included in the final report.

Rework and reevaluation activities were not documented in device history records for PQ lots (b) (4), where contents were reused from rejected cartons. Procedures for controlling nonconforming product were inadequate; labeling rejections detected by the vision system during PQ runs were not recorded, and there was no documentation of identification, evaluation, segregation, or disposition of nonconforming products, nor an evaluation for investigation needs.

Maintenance schedules for the vision system were not adequately established, as maintenance activities for