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FDA establishment 3006097795, Warana, Australia. Part of Fink Engineering'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: Jan 28, 2025
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 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.
21 CFR 820.186. QSR The quality system record has not been adequately maintained.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.25(b). Training records Personnel training is not documented.
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 by a designated person was not included in the record.
21 CFR 820.80(b). Lack of or inadequate receiving acceptance procedures Procedures for acceptance of incoming product 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
Warana, Australia. Part of