FDA EIR - Huntingdon Life Sciences, Inc. - January 28, 2011

An FDA surveillance inspection of Huntingdon Life Sciences, Inc., a non-clinical testing facility in East Millstone, NJ, was conducted from January 13 to January 28, 2011. The inspection assessed compliance with Good Laboratory Practice (GLP) regulations, specifically 21 CFR 58.808. Key areas reviewed included organization, study director responsibilities, quality assurance, facilities, equipment, and study conduct. The inspection resulted in two primary observations documented on an FDA Form 483. First, the facility's ambient pharmacy storage for test and control articles was inadequate, failing to maintain the necessary environmental conditions (e.g., humidity exceeding 40% for "dry place" requirements) to preserve product identity, strength, purity, and stability. Second, a non-clinical laboratory study (HLS Study (b)(4)) was not conducted in full accordance with its approved protocol. Additionally, discussions addressed several other areas. These included inconsistent archival timelines for study data and reports, insufficient detail in Institutional Animal Care and Use Committee (IACUC) meeting minutes regarding protocol discussions, and personnel observed smoking in scrubs and lab coats outside, raising potential contamination risks. Management committed to providing written responses with definitive corrective actions for the formal observations and acknowledged the need for improvements in the other discussed areas. The facility had previously implemented corrections for observations from a 2008 inspection.