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FDA establishment 3014549846, Missoula, Montana, United States. Part of OSRX, Inc.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 3
Official action indicated: 1
Last inspection ended: Oct 25, 2024
Warning letters: 1
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 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.
FDCA 501(a)(2)(A): Inadequate filter, final product sterilization1
Inspections
3 inspections, newest first
Ended
Product and area
Citations
Classification
Oct 25, 2024
Drugs · Drug Quality Assurance
6 cited references
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.
21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
FDCA 503B(a)(10)(B). Drug product container, fails to include The container of your outsourcing facility's drug products does not include information required by section 503B(a)(10)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
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 and followed.
Official Action Indicated (OAI)
Sep 23, 2021
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Apr 25, 2019
Drugs · Drug Quality Assurance
1 cited reference
FDCA 501(a)(2)(A). Inadequate filter, final product sterilization The filter intended to render final product sterile was not adequate to accomplish sterilization.
Voluntary Action Indicated (VAI)
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. 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 and warning letters
Missoula, Montana, United States. Part of