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Talk to a SpecialistTalk to a SpecialistCellEra LLC, a specification developer and distributor of sterile wound dressings, was found to manufacture adulterated medical devices that failed to comply with current good manufacturing practice (CGMP) requirements under 21 CFR Part 820. The company lacked written procedures for implementing corrective and preventive actions (CAPA) and failed to document corrective activities, such as changes made to product Instructions for Use for their Vitále Silver Calcium Alginate wound dressing. The FDA inspection conducted in June-July 2021 identified systemic quality system deficiencies in the company's manufacturing, packing, storage, and installation processes.