FDA 483 - Scientific Protein Laboratories, LLC - September 03, 2010

During an inspection, the FDA observed four violations at the facility.

**Observation #1** details issues with equipment used in manufacturing API intermediates. Specifically, stainless steel shovels and pitchforks used to transfer wet cake pancreatin from drums to dryers were observed to scrape the drum interiors, causing plastic shavings to contaminate the wet cake. An approximately quarter-inch blue plastic shaving was found in wet cake from lot #1208-1779, and a half-inch piece of plastic was hanging from a gouge in the drum. Used drums, both old and new (used since 7/7/10), exhibited scrapes, gouges, and missing plastic pieces. No extractable/leachable study had been completed on the drums used for storing wet cake pancreatin for up to weeks.

**Observation #2** states that a complaint regarding potential Oversulfated Chondroitin Sulfate (OSCS) in Heparin finished product lot #1035-0778, received on 10/9/08, was not formally investigated by the quality department until 9/9/09. The investigation, which concluded raw material lot #060600189 contained OSCS contamination and affected finished Heparin API lots #1035-0778 and #1035-0780 (both fully distributed), was not completed until 6/1/10