FDA EIR - Global Packaging Systems, Inc - December 06, 2018

An FDA routine Level I Quality System Inspection was conducted at Global Packaging Systems, Inc. from December 3 to December 6, 2018. This inspection, carried out under a federal contract aligned with the Compliance Program for Medical Device Manufacturers, assessed the company's operations as a registered contract manufacturer and repackager/relabeler of Class II non-prescription medical devices. The regulatory framework for this inspection was the Quality System Inspection Technique (QSIT).

The inspection reviewed several quality system procedures, including device history records, corrective and preventive actions (CAPAs), and production controls. While no formal observations (FDA Form 483) were issued, one verbal observation was raised. This concerned the "Nonconformance/CAPA Form," which was used for documenting complaints but did not explicitly reference whether a complaint required evaluation for a Medical Device Report (MDR) to the FDA.

Global Packaging Systems, Inc. promptly addressed and voluntarily corrected this verbal observation during the inspection period. Consequently, the inspection concluded with a "No Action Indicated (NAI)" classification, signifying that no further regulatory actions were required from the FDA following this review.