FDA 483 - Abbott Medical - October 02, 2012

The FDA Form 483 details observations from an inspection of a facility manufacturing leads, pacers, and ICDs.

**Complaint Handling Deficiencies:** Procedure #602277, "Product Experience Report Handling," lacks requirements for complete documentation of timely investigations and adequate data analysis for complaint trending. Section 7.3, "Data Analysis," fails to specify how analysis is conducted, reported, or evaluated, including scope and data sources for trend determination.

**Product Identification and Material Handling Issues:** 1. The software tool "redacted" used in the manufacturing/assembly clean room (HV and CRT Leads inspection stations) lacks full documentation to support its claimed non-impact on production. Instructions for scanning barcodes on leads are not part of production records. 2. Procedure #603348, "Material Handling Control," fails to ensure adequate documentation of line clearance activities. Form #101851, "Material Handling Control (MHC) Checklist," does not require documentation of the date line clearance was conducted or reviewed.

**Validation and Documentation Shortcomings:** * **Process Validation:** Performance qualification report for "redacted" (Protocol #90084631, Report #90087565) lacks full documentation of executed activities, including "redacted." * **Packaging Integrity:** Protocol #90088394 for "redacted" Products at Arec