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FDA establishment 3013927023, Columbia, Missouri, United States. Part of Apollo Care's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 4
Official action indicated: 4
Last inspection ended: Mar 27, 2025
Warning letters: 1
Recalls since 2016: 7
Inspections by Fiscal Year
FY2018 to FY2027 to date; 4 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 211.42(a). Buildings of Suitable Size, Construction, Location Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction and location to facilitate cleaning, maintenance, and proper operations.
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 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
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 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully 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.
Official Action Indicated (OAI)
Apr 5, 2023
Drugs · Drug Quality Assurance
None posted
Official Action Indicated (OAI)
Sep 8, 2021
Drugs · Drug Quality Assurance
None posted
Official Action Indicated (OAI)
Mar 13, 2018
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
Columbia, Missouri, United States. Part of