OKC Allergy Supplies, Inc. – FDA 483, Apr 26, 2013

The FDA Form 483 inspection revealed numerous deficiencies at the facility, impacting environmental quality, aseptic processing, product sterility, and quality system controls.

Environmental monitoring in Class 100 aseptic processing areas is inadequate and not representative of activities. SOP QC-033.00, requiring species-level identification of all environmental isolates, is not followed for Aseptic Filling Line and Allergenic Extract Filling. Investigations into environmental monitoring excursions are insufficient. A Class 100 surface sample from a Stopper Bowl showed an out-of-limit result.

Since November 5, 2012, nine commercial products experienced sterility failures, with five investigations incomplete or inadequate. Actions for non-viable particulate excursions during aseptic filling are inadequate, and alarms are not reacted to in real-time. The only non-viable particulate monitoring tube in the Class 100 Hood is poorly positioned.

Aseptic processing deficiencies include an operator's hand over open vials during filling. Limits for aseptic processing areas lack assurance of adequacy. Allergenic extract vials sampled for sterility testing are retained for use. The firm's procedures allow release of cloudy allergenic extracts. Validations for aseptically filled products are inadequate. No limits are established for ambient temperature exposure of allergenic extracts during various stages. Stoppers for allergenic extract vials are not demonstrated to be non-reactive, additive, or absorptive.

Facility and equipment maintenance issues include rubber bands holding a guide rail