Infusion Options, Inc. — FDA Warning Letter Findings

Your firm failed to follow written procedures regarding storage and warehousing of drug products (21 CFR 211.142).

Your firm failed to follow written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(b)).

Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).

Your firm failed to ensure that aseptic processing areas include floors, walls, and ceilings of smooth, hard surfaces that are easily cleanable (21 CFR 211.42(c)(10)(i)).

Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions (21 CFR 211.42(c)(10)(v)).

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). Outsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FDCA. FDA’s regulations regarding CGMP requirements for the preparation of drug products have been established in 21 CFR parts 210 and 211. FDA intends to…

Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.42(c)(10)).

Your facility failed to submit reports to FDA in June 2014, December 2016, December 2017, June 2018, December 2018, and June 2019, identifying the drug products that you compounded during the previous 6-month period. Because your compounded drug products did not meet all of the conditions of section 503B, they were not eligible for the exemptions in that section from the FDA approval requirements of section 505, the requirement under section 502(f)(1) that labeling bear…

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).

Your firm failed to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination (21 CFR 211.28(a)).

Your firm failed to ensure that only personnel authorized by supervisory personnel enter those areas of the buildings and facilities designated as limited-access areas (21 CFR 211.28(c)).

Some of your facility’s drug products did not include the following statements on the label: “This is a compounded drug,” “not for resale,” the date of compounding, and the lot or batch number. Some of your facility’s drug products did not include the following information on the container: information to facilitate adverse event reporting, http://www.fda.gov/medwatch and 1-800-FDA-1088.

Your firm failed to establish an adequate system for maintaining equipment used to control the aseptic conditions (21 CFR 211.42(c)(10)(vi)).