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DATE: SUBJECT: FROM: THRU: TO: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY REGIONS 77 WEST JACKSON BOULEVARD CHICAGO, ILLINOIS 60604 JUN 2 5 2019 CLEAN AIR ACT INSPECTION REPORT Scientific Protein Laboratories LLC (SPL ), Waunakee, Wisconsin Albana Bega, Environmental Engineer AECAB (MI/WI) Sarah Marshall, Section Chief AECAB (Ml/WI) File BASIC INFORMATION Facility Name: Scientific Protein Laboratories LLC (SPL) Facility Location: 700 E Main Street, Waunakee. Wisconsin Date oflnspection: May 3, 2019 EPA Inspector(s): 1. Albana Bega, Environmental Engineer 2. Alexandra Letuchy, Environmental Engineer Other Attendees 1. Bruce A. Greer, P.E., Manager - Environmental Health and Safety, SPL 2. Kevin R. Tebrinke, P.E., Vice President, Engineering, Maintenance & Health and Safety, SPL Contact Email Address: greerb@splpharma.com Purpose of Inspection: CAA compliance Facility Type: bulk pharmaceutical ingredient manufacturing Regulations Central to Inspection: Synthetic Minor, Non-Part 70 Operation Pem1it Arrival Time: 09:30 Departure Time: 13:00 Inspection Type: IZI Unannounced Inspection D Announced Inspection OPENING CONFERENCE IZI Credentials Presented IZI CBI warning to facility provided The following information was obtained verbally from Mr. Greer and Mr. Tebrinke unless otherwise noted. Company Ownership: In 2014 SPL was acquired by the Chinese company Shenzhen Hepalink Pharmaceutical Co., Ltd. Process Description: SPL is a bulk product biophannaceutical manufacturing company of active pharmaceutical ingredients. It is a global supplier of Heparin and Pancreatin enzymes. SPL claimed its process information as confidential business information. TOUR INFORMATION EPA toured the facility: Yes The facility was operating nonnally at the time of inspection. Data Collected and Observations: The following were observed during the tour: Raw material warehouse Heparin line Tank farm Photos and/or Videos: were not taken during the inspection. Field Measurements: were not taken during this inspection. RECORDS REVIEW Heparin Process Line P05 - Figure No. 4 Pancreatin Line 2 - Figure No. 5 Milling P25 - Figure No. 7 CLOSING CONFERENCE SIGNATURES Report Author: A>1.__.,-r Date: 6 / )._ r-( l,f Section Chief: ~ Date/, /J.!S);f t I Page 2 of 2