FDA EIR - Port Jervis Laboratories, Inc. - February 28, 2011

An FDA inspection of Kolmar Laboratories Inc., a contract manufacturer of over-the-counter drug and cosmetic products located in Port Jervis, NY, took place from February 18 to 28, 2011. This focused inspection evaluated the company's quality, equipment and facilities, and laboratory control systems, adhering to drug manufacturing inspection guidelines and Good Manufacturing Practices regulations. The inspection identified several issues, documented in an FDA-483 form. Key violations included the company's failure to thoroughly investigate batches that did not meet specifications, particularly concerning active ingredients such as Oxybenone and Octinoxate, without implementing appropriate corrective and preventive actions. Additionally, the firm was cited for not consistently following its own warehousing procedures for drug products, which resulted in raw materials lacking proper status labels and certain products being stored at incorrect temperatures. Laboratory records were also found to be incomplete, specifically missing detailed calculations for release testing. Verbal observations from the inspection highlighted concerns with unrepresentative in-process sampling, incomplete batch records, and an uncalibrated laboratory fume hood. Kolmar Laboratories Inc. acknowledged these observations and committed to addressing the identified deficiencies. The company pledged to submit a formal written response to the district office within 15 business days, outlining their corrective actions. During the inspection, some immediate voluntary corrections were initiated, including the calibration of the fume hood and the implementation of new temperature and humidity monitoring forms.