FDA 483 - Central Admixture Pharmacy Services, Inc. - February 05, 2016

This FDA Form 483 document details observations from an inspection of CAPS, a facility with 24 sites. The inspection identified two primary issues.

Firstly, the responsibilities and procedures of the quality control unit are not fully followed. The Director of Quality Assurance stated he has ultimate authority over quality issues across all 24 CAPS sites. However, the CAPS Operating Procedure COP-CAPS-4000004, "Quality - Upper Management Notification," dated 06-03-2014, is deemed insufficient. It does not fully describe all roles and responsibilities of the corporate headquarters' Quality Control Unit concerning all 24 CAPS sites.

Secondly, investigations of unexplained discrepancies did not extend to other batches of the same drug product. Specifically, Complaint Investigation 37-150123-015 involved a cardioplegia drug that reportedly did not stop the heart during surgery. The firm's investigation identified IV Technician redacted as involved in producing drugs from lots #37-80463-05, #37-80463-06, and #37-79031-02, made on 1/13/15, 1/13/15, and 1/8/15, respectively, which were supplied to the complaining hospital. Despite this, the investigation concluded "no issue" and did not