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FDA establishment 3007942369, Latham, New York, United States. Part of Fallon Wellness Pharmacy, L.L.C.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
21 CFR 211.167(a). Sterility/pyrogen-free testing Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.
21 CFR 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
21 CFR 211.42(c)(10)(vi). Equipment to control conditions Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
21 CFR 211.42(c)(10)(v). Cleaning System Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
21 CFR 211.46(c). Exhaust systems inadequate to control air contamination Adequate exhaust systems or other systems to control contaminants are lacking in areas where air contamination occurs during production.
21 CFR 211.56(b). Written sanitation procedures lacking There is a lack of written procedures assigning responsibility, providing cleaning schedules and describing in sufficient detail the methods, equipment and materials to be used for sanitation.
21 CFR 211.42(c). Defined areas of adequate size for operations The separate or defined areas necessary to prevent contamination or mix-ups are deficient.
21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
21 CFR 211.166(a). Lack of written stability program There is no written testing program designed to assess the stability characteristics of drug products.
Voluntary Action Indicated (VAI)
Apr 2, 2015
Drugs · Drug Quality Assurance
None posted
Official Action Indicated (OAI)
Mar 10, 2015
Drugs · Drug Quality Assurance
None posted
Official Action Indicated (OAI)
Warning Letters
Letters naming this establishment; each opens the letter
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard, warning letters and enforcement reports
Latham, New York, United States. Part of