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FDA establishment 3007021905, Mumbai, India. Part of Cipla's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.
Inspections: 3
Official action indicated: 1
Last inspection ended: Mar 18, 2016
Warning letters: 0
Import refusals since 2024: 18
Import refusals 2014 to 2023: 23, first Nov 21, 2014
21 CFR 314.80(b). Failure to develop written procedures Written procedures have not been developed for the surveillance, receipt, evaluation, and reporting to FDA of post marketing adverse drug experiences.
21 CFR 314.80(c). Failure by applicant to report ADE Adverse drug experience information has not been reported to FDA.
21 CFR 314.80(c)(2). Late submission of annual safety reports Not all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the application.
21 CFR 314.80(j). Failure to maintain records Records relating to all adverse drug experiences known to you, including raw data and any correspondence, have not been maintained for the required ten year period.
21 CFR 314.81(b)(2). Timely submission An annual report was not submitted each year and within 60 days of the anniversary date of U.S. approval of the application to the FDA division responsible for reviewing the application.
21 CFR 314.80(c)(1)(i). Late submission of 15-day report Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.
Official Action Indicated (OAI)
Sep 22, 2011
Drugs · Bioresearch Monitoring
1 cited reference
21 CFR 314.81(b)(2). Timely submission An annual report was not submitted each year and within 60 days of the anniversary date of U.S. approval of the application to the FDA division responsible for reviewing the application.
Voluntary Action Indicated (VAI)
Import Refusals
18 refused shipment lines since 2024, grouped by product and charges
NORFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC)Drugs · 61GCA84
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
Mumbai, India. Part of