FDA EIR - P & L Development, LLC - November 13, 2018

An FDA inspection of P & L Developments, LLC, a packager and labeler of human prescription and over-the-counter drugs, was conducted from November 7-13, 2018. This cGMP inspection, performed under CPGM 7356.002 "Drug Manufacturing Inspections," focused on Quality, Facilities and Equipment, Materials, and Packaging & Labeling systems. It also served as a follow-up to a previous inspection in September 2014, which cited inadequate warehousing procedures and insufficient review of unexplained batch discrepancies; these issues were deemed adequately corrected. During the current inspection, two primary issues were identified. First, the firm was found to be using a non-controlled Excel sheet for documenting critical stability data received from a third party. This method was considered inadequate for determining product expiry, packaging and labeling requirements, distribution decisions, and annual product reviews. Second, the retain sample inspection procedure was found lacking as it did not include checks for the actual product's organoleptic qualities, instead relying solely on container integrity for evaluation. This practice was noted as insufficient. While the facilities themselves appeared clean, well-lit, and in good repair, the identified procedural deficiencies are significant. As a result of these findings, a Form FDA 483 was issued to company management, signaling the need for corrective actions to address the identified regulatory deviations.