FDA 483 - Ballard Plaza Pharmacy I, Inc. - May 17, 2016

The FDA Form 483 details numerous deficiencies observed during an inspection.

**Facility and Environment:** * A partially detached wood panel exposing un-cleanable fibrous material was found on an ISO 5 laminar flow hood (LFH). * Non-sterile wipes were used for cleaning ISO 5 LFH, ISO 7 clean room, and ISO 8 anteroom surfaces. * Soiled material was observed on the pre-filter grate of an ISO 5 LFH and on a telephone handset in the ISO 7 clean room. * Rust was present on a mobile cart in the ISO 7 clean room (lower basket, wheel casters, screw heads). * Residue was observed on classified area sides of glass windows in the ISO 8 anteroom and ISO 7 clean room. * An eight-inch crack was noted on the glass window between the ISO 8 anteroom and ISO 7 clean room. * Positive air pressure differential was not continuously monitored between classified areas prior to November 12, 2015.

**Equipment and Validation:** * No bioburden limits were established for the (b)(4) used in sterilization of sterile drug products (e.g., Cataract Block Solution, Vancomycin HCl, Apomorphine HCl). * The (b)(4) was not validated for its intended purpose, including effective sterilization of oils, ophthal