FDA 483 - Abbott Medical - October 17, 2012

The FDA Form 483 details numerous deficiencies in the facility's quality system and manufacturing processes.

**Process Validation Issues:** The process validation protocol for (b)(4) machines performing (b)(4) or (b)(4) and (b)(4) was inadequate. It failed to evaluate differences between machines installed from 1999-2011, did not specify installation and verification of lead holders, had unclear statistical rationale for sample size, and used an acceptance criterion of 95% of the population exceeding specifications. Additionally, (b)(4) could not verify results of 3 cross-sectioned samples, and pressure/flow of (b)(4) delivered to (b)(4) was not measured at endpoints of use.

**Design Verification Deficiencies:** Three in-house test methods for design verification were not validated, including those for (b)(4) tip (b)(4), (b)(4) change, and (b)(4) condition. Design verification testing for the (b)(4) test did not follow procedures, as leads were tested once instead of five times to determine a mean. Durata (b)(4) design verification occurred before approval of lead inputs. (b)(4) design verification was conducted after leads were implanted in canines for design validation.

**Risk Analysis and Design History File:** Durata risk analyses were inadequate, lacking predetermined acceptance criteria for canine testing, failing to evaluate