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FDA establishment 3013783260, Oakmont, Pennsylvania, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 1
Official action indicated: 0
Last inspection ended: Nov 28, 2017
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 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 50.20: Consent not obtained, exceptions do not apply1
Inspections
1 inspections, newest first
Ended
Product and area
Citations
Classification
Nov 28, 2017
Devices · Bioresearch Monitoring
3 cited references
21 CFR 812.110(a). Subject participation prior to study approval Subjects were allowed to participate in an investigation prior to obtaining IRB approval to conduct the investigation.
21 CFR 812.140(a)(3)(i). Investigator records of informed consent inadequate Records documenting that informed consent was obtained for each subject prior to participation in the study are not all complete.
21 CFR 50.20. Consent not obtained, exceptions do not apply Legally effective informed consent was not obtained from a subject or the subject's legally authorized representative, and the situation did not meet the criteria in 21 CFR 50.23 - 50.24 for exception.
7382.850, Inspection of Medical Device Manufacturers
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
Oakmont, Pennsylvania, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.