Scientific Protein Laboratories, LLC – FDA 483, Dec 15, 2009

This FDA Form 483 was issued to David G. Strunce, President and CEO of Scientific Protein Laboratories, LLC, an API Manufacturer located at 700 E. Main Street, Waunakee, WI 53597. The inspection occurred on November 30, December 1-4, 7, 8, and 15, 2009.

The inspection revealed six observations:

1. **Deviations from normal production are not always documented and explained.** For example, pancreatin batch 1206-1495, load #2, was loaded into a dryer with partially filled trays extending off shelves, a known recurring issue. The amount loaded exceeded the dryer's validated maximum load, and the current SOP 17-0005 still allowed the former, incorrect amount. No deviation or discrepancy was recorded.

2. **Materials are not stored to prevent degradation, contamination, and cross-contamination.** Frozen pancreas glands were received and stored in a freezer room with a dirty floor, wood pieces from damaged pallets, heavy black dust on goods, dark material on curtains, and particulate from blowers. Re-stacked glands on wooden pallets with inadequate cardboard and plastic wrap exposed them to dust and pallets.

3. **Process validation efforts are unsuitable, missing critical parameters.** A protocol for pancrelipase blending has not been executed, and there is no validation