FDA EIR - Delsam Pharma LLC - March 24, 2023

An FDA inspection of Delsam Pharma LLC, an own-label distributor of over-the-counter ophthalmic drug products, was conducted from March 6 to March 24, 2023. The inspection, initiated by the CDER Office of Manufacturing, focused on the company's quality system, as no manufacturing, packaging, labeling, testing, or warehousing activities occur on-site. The inspection revealed significant deficiencies, documented in an FDA Form 483 issued to President/Owner Mr. Kuppusamy G. Arumugam. Main issues included the absence of a functional quality control unit, with no agreements or qualification processes for its contract manufacturer or warehouse, and a lack of written procedures for critical quality functions such as deviation handling, stability data review, and release specifications. Discrepancies in Certificates of Analysis from the manufacturer were also noted. Furthermore, drug products were stored for over a month in a public facility without temperature monitoring, compromising assurance of appropriate storage conditions (15-30 0C and 20-25 0C). The company lacked written procedures for handling complaints, including reports of adverse events like conjunctivitis and severe eye infections, which were neither documented nor investigated. A system for tracing drug product lots for recall purposes was also missing, alongside a general absence of recall procedures. Finally, annual product quality reviews were not conducted. These violations align with regulations under 21 CFR Part 211 for Current Good Manufacturing Practice. Mr. Arumugam committed to submitting a written response to the FDA within 15 business days.