FDA 483 - Hospira, Inc. - June 17, 2011

This FDA Form 483, issued to Hospira, Inc., a pharmaceutical and device manufacturer and gamma irradiator in Rocky Mount, NC, following an inspection from May 16 to June 17, 2011, details 18 observations of objectionable conditions.

Key issues include: * **Quality System Deficiencies:** No written stability testing program for drug products, specifically lacking routine sterility and container-closure integrity testing. The "Maintenance of Sterility" (MOS) program lacks justification for its representative sampling. * **Quality Control Unit Failures:** Contradictory instructions in MOS procedures and inadequate review of cross-contamination incidents (Dexmedetomidine HCL Injection). * **Investigation Failures:** Inadequate review of unexplained discrepancies and out-of-specification (OOS) results, including a sterilization failure (Lidocaine Hydrochloride) and a stability failure (Magnesium Sulfate). OOS laboratory results were dismissed without scientific justification (Dopamine HCl, Atropine Sulfate). Investigations did not extend to other potentially affected drug products (Sodium Chloride Injections). * **Contamination Control:** Deficient separate/defined areas and control systems, with bulk APIs (desmopressin, calcitrol) improperly stored and inconsistently coded in inventory. * **Equipment and Facility Issues:** Equipment not of appropriate design or suitably located, leading to operational difficulties and potential contamination (e.g., aseptic fill