Pro Paks, LLC – FDA Warning Letter, May 31, 2011

On June 24, 2011, the FDA issued a Warning Letter to Pro-Paks, LLC, following an inspection from April 25 to May 31, 2011, at their Middletown, CT facility. The inspection revealed that the firm's sterile, single-use, ophthalmic surgical kits are adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act, as their manufacturing, packing, storage, or installation methods do not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1) Failure to validate processes, such as gamma irradiation sterilization and pouch seal integrity, after significant changes like a new manufacturing location in 2008, as required by 21 CFR §820.75(a). 2) Failure to identify the acceptance status of products (conformance/nonconformance) throughout manufacturing, packaging, and labeling, per 21 CFR §820.86. 3) Failure to adequately document acceptance activities, specifically the review and approval of lots returned from a contract sterilizer, as required by 21 CFR §820.80(e). 4) Failure to establish and maintain procedures for purchased or received products/services, particularly for contract sterilization, per 21 CFR §820.50.

The firm's May 23, 2011, response was deemed inadequate. Pro-Paks, LLC must take prompt corrective action and notify the FDA within fifteen working days, providing documentation and a timetable for implementation. Failure to correct these violations may result in regulatory actions, including seizure, injunction, civil money penalties, and impact on federal contracts, premarket approvals, and Certificates to Foreign Governments. The letter emphasizes the firm's responsibility to investigate and correct all underlying quality system issues.