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Talk to a SpecialistTalk to a SpecialistOptikem International, Inc., a manufacturer of Sereine brand ophthalmic medical device solutions, failed to comply with current good manufacturing practice (CGMP) requirements under 21 CFR Part 820. During a February-March 2024 inspection, FDA investigators found that the company's sterile devices were adulterated due to inadequate process validation, including failure to perform required annual aseptic media fills and lack of procedures governing the mixing and heat treatment sterilization steps. The company's Process Validation procedure, unchanged since 1998, did not meet regulatory requirements for documentation, qualified personnel, and validation protocols established under 21 CFR 820.75.