FDA EIR - EMSL Analytical, Inc. dba MPL Laboratories - October 03, 2016

An FDA surveillance inspection of EMSL Analytical, Inc. dba MaryPaul Laboratories, a microbiology control testing laboratory in Sparta, NJ, was conducted from September 27 to October 3, 2016. The inspection, performed under the Current Good Manufacturing Practices (cGMP) framework for Drug Manufacturing Inspections (Compliance Program 7356.002), focused on the firm's Laboratory Control, Materials, and Quality Systems. While the inspection confirmed the firm continued to operate as a contract microbiology laboratory with no significant process changes since its acquisition by EMSL in October 2015, a key observation was the lack of a documented process for sample label reconciliation. The firm generated anticipated sample labels monthly and shredded unused ones without proper tracking. This practice raised concerns about potential mislabeling. During the close-out meeting, the company committed to implementing a new process to document the destruction of unused sample numbers, including the date and initials of the performing individual, within the sample log book. No FDA Form 483, Inspectional Observations, was issued, indicating that the matter was addressed through discussion and immediate corrective action by management.