Site records / Andhra Pradesh / FEI 3009093782
Hetero Labs LimitedAnakapalli District, Andhra Pradesh
FDA-registered drug establishment in Anakapalli District, Andhra Pradesh: api manufacture. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 5
- Last inspection
- Nov 2022 · VAI
- Warning letters to this FEI
- 0
- Import alerts at this address
- 0
- 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
5 FDA inspections of this FEI, by end date; 5 with a posted classification.
- 8 Nov 2022VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 14 May 2019OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
- 18 Aug 2017VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 29 Sep 2014VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 15 Dec 2011NAI · 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
No listing in force under this firm's name.
Other registered sites of Hetero (unlisted)
- Hetero Drugs LimitedSangareddy district, Telangana
- 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 LimitedHobli Vemagal Kolar, Karnataka
Registration
- FEI
- 3009093782
- DUNS
- 650563526
- Registered as
- Hetero Labs Limited
- Registrant
- Hetero Labs Limited
- Address
- Unit IX, Plot No. 2, Hetero Infrastructure SEZ Ltd., N. Narasapuram Village, Nakkapalli (Mandal), Anakapalli District, Andhra Pradesh 531081, 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.