FDA EIR - Port Jervis Laboratories, Inc. - January 25, 2018

An FDA inspection of Kolmar Laboratories Inc. in Port Jervis, NY, was conducted from January 19 to January 25, 2018. The inspection, performed under the drug manufacturing Good Manufacturing Practices (GMP) regulatory framework (C.P.7356.002), focused on the quality system, material management, packaging and labeling, and laboratory systems. Kolmar Laboratories is a contract manufacturer of topical over-the-counter (OTC) drug products, including anti-acne, sun protection, and anti-fungal items, distributed across the United States.

While no formal FDA-483 observations were issued, several significant verbal observations were made. Inspectors noted the extensive use of wooden pallets in manufacturing and weighing areas, raising concerns about potential microbiological contamination and foreign particles. Additionally, a lack of automated login security was observed on an HPLC system in the analytical laboratory, where a previous user remained logged in. In the microbiology laboratory, incubators lacked continuous chart recorders for temperature monitoring, posing a risk to product quality.

Kolmar Laboratories management acknowledged these observations and committed to immediate corrective actions. They agreed to address the wooden pallet issue, implement automatic lockout features for laboratory computer systems, and re-instate chart recorders for incubators to ensure continuous temperature compliance. The firm pledged to formally respond to the district office regarding these corrections.