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FDA establishment 3008089360, Pleasanton, California, United States. Part of Trireme Medical, Inc.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 4
Official action indicated: 0
Last inspection ended: Jun 17, 2022
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 812.43(c)(5). No financial disclosure info in investigator agreement A signed agreement was not obtained from each participating investigator that includes a commitment to promptly update financial disclosure information if any relevant changes occur during the investigation and for one year following completion of the study.
21 CFR 812.40. Sponsors' general responsibilities For an investigational study, proper monitoring was not ensured.
21 CFR 812.43(c). No investigator agreement A signed investigator agreement was not obtained from each participating investigator .
21 CFR 812.140(b)(3). Sponsor records of investigator agreements inadequate Signed investigator agreements that include the required financial disclosure information are not all accurate.
21 CFR 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures for design change have not been adequately established.
21 CFR 806.20(b)(4). Justification for not reporting A justification for not reporting the correction or removal action to FDA that included conclusions, follow-ups and reviews by a designated person was not included in the record.
21 CFR 820.30(h). Design transfer - Lack of or inadequate procedures Procedures for design transfer have not been adequately established.
21 CFR 820.30(c). Design input - Lack of or inadequate procedures Procedures for design input have not been adequately established.
21 CFR 820.30(d). Design output - Lack of or inadequate procedures Procedures for design output have not been adequately established.
21 CFR 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures have not been adequately established to control product that does not conform to specified requirements.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
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
Pleasanton, California, United States. Part of