FDA WARNING_LETTER - Hospira, Inc. - November 15, 2013

On September 30 – November 15, 2013, the FDA inspected Hospira's Rocky Mount, NC facility, which manufactures medical devices like the Sterile Empty PCA vial and Injector. The inspection revealed these devices are adulterated under Section 501(h) of the Act, as manufacturing, packing, storage, or installation methods, facilities, or controls do not conform to Current Good Manufacturing Practice (CGMP) requirements of 21 CFR Part 820 (Quality System Regulation).

Violations include: 1. **Complaint Handling (21 CFR 820.198(c)):** Complaints involving potential specification failures were not adequately reviewed. Specifically, PCA injector and vial, LOT (b)(4), was released despite failing post-ETO leak testing, and a field malfunction (MDR 1021343-2012-00181) occurred. The FDA requested the "Justification of liquid pressure test of PCA injectors" memo dated October 18, 2012, and water test data for evaluation. 2. **Process Validation (21 CFR 820.75(b)(2)):** No documentation of monitoring and control methods and data for a validated process, specifically regarding product bioburden for devices in the EO sterilization process. The FDA requested additional information on the adequacy of the aseptic assembly area. 3