Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
FDA establishment 3004944585, Bangalore, India. Part of Healthium Medtech Limited's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
21 CFR 820.40(a). Not approved or obsolete document retrieval Documents that were not approved were observed at a location where they are being used.
21 CFR 820.22. Quality Audit/Reaudit - conducted Quality audits were not conducted to verify that the quality system is effective in fulfilling your quality system objectives.
21 CFR 820.30(a). Design control - no procedures Procedures to control the design process of the device were not established, defined, documented, complete, and implemented.
21 CFR 820.184. Lack of or inadequate DHR procedures Procedures have not been established, defined, documented, and completed to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record and the Quality Systems regulation.
21 CFR 820.70(g)(2). Periodic equipment inspection lack of or inadequate procedu Periodic inspections of equipment were not conducted in accordance with established procedures to ensure adherence to applicable maintenance schedules .
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed and maintained.
21 CFR 820.181(c). DMR QA procedures and specifications The device master record does not include or refer to the location of all quality assurance procedures and specifications.
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
Bangalore, India. Part of