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FDA establishment 3013634985, Buena Park, California, United States. Part of Guidemia Technologies's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 1
Official action indicated: 0
Last inspection ended: Jul 6, 2026
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 830.310(b). GUDID Information required for unique device identification. The correct unique device identifier (UDI) information regarding device identifier portion of the UDI assigned to the version or model was not provided to the FDA via the Global Unique Device Identification Database (GUDID).
ISO 13485:2016 Clause 8.2.2. Complaint handling records not maintained Complaint handling records were not adequately maintained.
ISO 13485:2016 Clause 6.2(b). Personnel training not provided Training has not been adequately provided, or other actions needed taken, to achieve or maintain the necessary personnel competence.
ISO 13485:2016 Clause 8.5.2. Corrective action records not maintained Records of corrective actions, including the results of any investigations and actions taken, were not adequately maintained.
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
Buena Park, California, United States. Part of