Scientific Protein Laboratories, LLC – FDA 483, Jun 9, 2009

This FDA Form 483 was issued to Scientific Protein Laboratories, LLC, an API Manufacturer located at 700 East Main Street, Waunakee, WI 53597. The inspection occurred from April 27 to May 1, and June 6-8, 2009.

Key observations include:

**Quality Systems:** * The Drug Master File (DMF) 9649, dated 12/19/08, does not permit QA-released blends from rejected APIs. Specifically, rejected API lot 1208-1433A (high spore-forming bacteria) was reprocessed into lot 1208-1486, which was then used to manufacture blend lots 1297-0323A, 1297-0323B, and 1297-0323C, all showing high microbial counts. These blends were subsequently used to produce finished products (e.g., 1208-1651A) that were QA released despite high microbial counts. * Rejected PEC High Lipase API lot 1208-1129A was used as pancreatin activator for finished API lots 1206 and 1208, resulting in contaminated batches (e.g., 1208-1