Nebraska Methodist Hospital – FDA 483, Jul 14, 2014

During an inspection from June 24, 2014, to July 14, 2014, Nebraska Methodist Hospital, a producer of sterile drug products located at 8303 Dodge St, Omaha, NE 68114-4108, received a Form 483 with six observations.

Observation 1 noted deficiencies in cleaning and disinfecting aseptic processing areas. The firm failed to document cleaning of the "Clean Room," including IV hoods, and did not document cleaning with a sporicidal agent. Records for cleaning IV hoods, bins, carts, and shelving were deficient for April, May, and June 2014.

Observation 2 cited deficiencies in environmental monitoring. Environmental monitoring was not conducted daily where sterile drug products are produced. Required surface sampling was not completed for several months (July, August, September 2013, February, May 2014), and raw data results for surface sampling were not kept. Procedures and records for environmental monitoring of ISO 5 areas and daily personnel monitoring were absent.

Observation 3 stated that procedures to prevent microbiological contamination were not established, written, and followed, specifically regarding the absence of documented smoke studies to verify airflow patterns under static or dynamic conditions.

Observation 4 concerned inappropriate personnel clothing. Personnel producing sterile drug products used non-sterile gowns, masks, and hair nets, and had exposed skin around the eyes, head, and neck