FDA 483 - TRI-PAC, INC. - January 15, 2026

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.