FDA 483 - Tessy Plastics Corp. - April 16, 2026
An FDA inspection of Tessy Plastics Corp., a medical device contract manufacturer in Skaneateles, NY, revealed significant deficiencies in their cleanroom operations. The firm failed to adequately document infrastructure maintenance activities and procedures for cleanroom cleaning, leading to visible particulate accumulation on manufacturing equipment. Additionally, the company did not properly monitor and control the work environment, as evidenced by an uninvestigated particle count excursion and a lack of required retesting.
- Office
- New York District Office
- Person
ID · e667370f-7118-4be8-b1c6-c9baffc23ee3
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