Site records / Andhra Pradesh / FEI 3004149463
Divi's Laboratories LimitedVisakhapatnam District, Andhra Pradesh
FDA-registered drug establishment in Visakhapatnam District, Andhra Pradesh: analysis, api manufacture. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 8
- Last inspection
- Jul 2024 · VAI
- Warning letters to this FEI
- 1
- 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
8 FDA inspections of this FEI, by end date; 8 with a posted classification.
- 19 Jul 2024VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 31 Jan 2020NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 19 Sep 2017VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 6 Dec 2016OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
- 19 Feb 2016NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 6 Jun 2014VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 19 Jul 2012VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 9 Apr 2009VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
Warning letters and compliance actions
- 13 Apr 2017Warning Letter · CDER
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.
- 13 Oct 2022Import alert 66-79 · Published address is not this site SourcePublished address: 7 - 1 - 77 E 1 303 Divi Towers , Hyderabad, Telangana INDIA
Form 483s released by FDA
Other registered sites of Divi's Laboratories
- Divi's Laboratories LimitedYadadri Bhuvanagiri District, Telangana
Registration
- FEI
- 3004149463
- DUNS
- 676446492
- Registered as
- DIVI'S LABORATORIES LIMITED
- Registrant
- DIVI'S LABORATORIES LIMITED
- Address
- Unit-2, Chippada Village, Annavaram Post Bheemunipatnam Mandal, Visakhapatnam District, Andhra Pradesh 531162, India (IND)
- Operations
- ANALYSIS, 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.