483
TRI-PAC, INC.FDA 483 - TRI-PAC, INC. - January 15, 2026
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Record Details
TRI-PAC, INC. in South Bend, IN, a CDMO, was cited for deficiencies in equipment cleaning and maintenance during drug product manufacturing. The inspection revealed that a filler was used for multiple batches without cleaning, and the firm lacked scientific evidence to support the dirty hold time for this equipment. This indicates a potential risk to the safety, identity, strength, quality, and purity of the drug product.
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ID · 30e9f69a-79db-4333-aabf-2dce9a0aaa82