Site records / Telangana / FEI 3003510514
Hetero Drugs LimitedSangareddy district, Telangana
FDA-registered drug establishment in Sangareddy district, Telangana: api manufacture. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 6
- Last inspection
- May 2025 · VAI
- Warning letters to this FEI
- 0
- Import alerts at this address
- 0 of 1 under the name
- US border refusals, 2 years
- 0
This site, graded.
Every fact sourced.
- A grade from A to E on a registered ten-factor rubric, with the fact behind every factor
- Every posted FDA citation, sorted into failure categories and set against Indian drug inspections
- Warning-letter violations, numbered and labelled
- Import-alert history rebuilt from the archive, each listing checked against this address
- Border refusals by product, and the company's other sites, each graded
- A hash of every source read, so the PDF can be checked against the record
On 2022–26 inspections the rubric never saw, grade E sites were classified OAI 26.5% of the time and grade A sites 4.0%.
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Inspections
6 FDA inspections of this FEI, by end date; 6 with a posted classification.
- 16 May 2025VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 14 Feb 2020VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 2 Mar 2018VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 25 Feb 2016NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 2 May 2014VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 11 Nov 2010NAI · No Action IndicatedDrug Quality Assurance · no citations posted
Warning letters and compliance actions
No FDA compliance action recorded against this FEI or letter to its name.
Import alerts in force
Import-alert pages list a firm name and an address, never an FEI. Each listing under this firm's name is shown with the address FDA published and whether it is this site's.
- 30 Sep 2009Import alert 66-66 · Published address is not this site SourcePublished address: 7 1 Hetero House # 8 - 3 - 166 , Hyderabad, Telangana INDIA
Form 483s released by FDA
- 2 Mar 2018Form 483 · 3 pages Source
Other registered sites of Hetero (unlisted)
- Hetero Drugs LimitedAnakapalli district, Andhra Pradesh
- Hetero Drugs LimitedHyderabad, Telangana
- Hetero Drugs LimitedSangareddy district, Telangana
- Hetero Labs LimitedSangareddy, Telangana
- Hetero Labs LimitedHyderabad, Telangana
- Hetero Labs LimitedMahabubnagar, Telangana
- Hetero Labs LimitedMahabubnagar, Telangana
- Hetero Labs LimitedAnakapalli District, Andhra Pradesh
- Hetero Labs LimitedAnakapalli District, Andhra Pradesh
- Hetero Labs LimitedHobli Vemagal Kolar, Karnataka
Registration
- FEI
- 3003510514
- DUNS
- 650433076
- Registered as
- Hetero Drugs Limited
- Registrant
- Hetero Drugs Limited
- Address
- Unit I, Sy. No. 213, 214 & 255, Bonthapally Village, Gummadidala Mandal,, Sangareddy district, Telangana 502313, India (IND)
- Operations
- API MANUFACTURE
- Registration expires
- 31 Dec 2026
Sources: FDA drug establishment registrations, FDA Data Dashboard inspections and compliance actions, import-alert pages, warning letters, import refusals and the FDA reading room, as held in Counterfoil's point-in-time corpus. No matched action does not establish compliance, and FDA registration is not FDA approval. Sources and coverage.