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

On January 20, 2011, the FDA issued a Warning Letter to Scientific Protein Laboratories LLC following an inspection from July 28 to September 3, 2010, which identified significant Current Good Manufacturing Practice (CGMP) deviations. These deviations render the firm's drugs adulterated under 21 U.S.C. § 351(a)(2)(B). The FDA found the firm's September 13, 2010, response lacking sufficient corrective actions.

Key violations include: 1. **Failure to investigate complaints timely and comprehensively:** A formal investigation into potential Oversulfated Chondroitin Sulfate (OSCS) contamination in Heparin Sodium USP (lot 1035-0778) was delayed from October 2008 to September 2009. The investigation also failed to extend to other affected lots promptly. 2. **Improper evaluation of a contract laboratory:** The firm failed to audit a contract testing laboratory, (b)(4), as required by SOP 65-9663, leading to the submission of inaccurate data to the FDA. 3. **Inappropriate equipment design:** Utensils used to remove pancreatin wet cake from (b)(4) drums caused plastic shavings to contaminate the product (lot 1208-1779). The proposed visual inspection corrective action was