FDA establishment 3011895410, Tirupati, India. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.
FY2018 to FY2027 to date; 0 classified OAI
A hatched bar is a year that is not over, so its count covers only part of the year.
Inspections citing each reference
| Ended | Product and area | Citations | Classification |
|---|---|---|---|
| Dec 17, 2025 | Drugs · Drug Quality Assurance | 5 cited references
| Voluntary Action Indicated (VAI) |
| Feb 28, 2020 | Drugs · Drug Quality Assurance | None posted | Voluntary Action Indicated (VAI) |
| Apr 19, 2019 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Mar 20, 2019 | Drugs · Bioresearch Monitoring | None posted | No Action Indicated (NAI) |
| Oct 26, 2018 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Product | Charges | Latest |
|---|---|---|
| ACETAMINOPHEN (ANALGESIC)Drugs · 60LCY01 | Aug 16, 2024 | |
| TENOFOVIR DISOPROXIL FUMERATEDrugs · 62VDA15 | Jul 17, 2024 | |
| TENOFOVIR DISOPROXIL FUMERATEDrugs · 62VDE15 | Apr 30, 2024 |
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
Tirupati, India. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.