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Talk to a SpecialistTalk to a SpecialistMicrospecialties, LLC, a contract manufacturer of Class I and II ophthalmic surgical devices including sterile I-PACK injection kits, punctum plugs, and microkeratome blades, was cited for manufacturing adulterated devices that failed to comply with current good manufacturing practice (CGMP) requirements under 21 CFR Part 820. An FDA inspection from January through February 2025 identified violations including failure to establish and maintain procedures for finished device acceptance to ensure production batches met acceptance criteria, specifically regarding the implementation of sterilization process control procedures and sterile product release documentation. The company's quality assurance response dated March 4, 2025 did not adequately address the inspectional observations documented on FDA Form 483.