Recipient: Mainline Technology, Inc
Product: Mainline Confirms Strep A, Mainline Confirms Strep A Dots, FYI hCG Urine One-step Pregnancy Test, Mainline Confirms hCG One-step Pregnancy Test, Mainline Confirms III hCG One-Strep Pregnancy Test, and Mainline hCG Accuracy Check pos+ and neg- controls.
Our inspection revealed that these devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or approved applications for investigational device exemptions (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The devices are also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce these devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. Title 21, Code of Federal Regulations (CFR), 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed. Our inspection also revealed that your Mainline Confirms Strep A device is misbranded within the meaning of section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. 360(i), and 21 CFR Part 806 -Reports of Corrections and Removals regulation.
The above-referenced inspection also revealed that these devices are adulterated within the meaning of Section 501(h) of the Federal Food, Drug, and Cosmetic Act the Act [21 U.S.C. 351(h)], in that the methods used in, or the facilities or controls used for their manufacture, packing, storage, or installation are not in conformance with the current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation, as specified in 21 CFR Part 820. Significant deviations include, but are not limited to, the following:
8. Failure to validate with a high degree of assurance and approve according to established procedures a process whose results cannot be fully verified by subsequent inspection and test, and failure to document such validation activities and results, as required by 21 CFR 820.75(a). For example, there is no documentation of validation of your firm’s manufacturing process, cleaning operations, software calculations or filling operations for your strep A and hCG in vitro diagnostics. [See inspectional observation 9.]
FDA Detroit District Office