Site records / Maharashtra / FEI 3009278506

Wockhardt LimitedAurangabad, Maharashtra

FDA-registered drug establishment in Aurangabad, Maharashtra: manufacture. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.

Inspections posted
1
Last inspection
Jan 2016 · OAI
Warning letters to this FEI
0
Import alerts at this address
0 of 3 under the name
US border refusals, 2 years
0
The site dossier

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

1 FDA inspection of this FEI, by end date; 1 with a posted classification.

  1. 12 Jan 2016OAI · Official Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

  1. 25 Nov 2013Warning letter to Wockhardt Limited SourceCGMP/Finished Pharmaceuticals/Adulterated · issued to the firm name; FDA does not tie it to this FEI
  2. 18 Jul 2013Warning letter to Wockhardt Limited SourceCGMP/Finished Pharmaceuticals/Adulterated · issued to the firm name; FDA does not tie it to this FEI

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.

  1. 5 Aug 2016Import alert 66-40 · Published address is not this site SourcePublished address: Sf-12 Shrinathji Arcade Plot 138 , Bulk Drug Division; Karmatur Road , Ankleshwar, Gujarat INDIA
  2. 26 Nov 2013Import alert 66-40 · Published address cannot be tied to one site SourcePublished address: L-1, MIDC Area, Jalgaon Road 43 , Chikalthana , Aurangabad, Maharashtra INDIA
  3. 22 May 2013Import alert 66-40 · Published address cannot be tied to one site SourcePublished address: H - 14/2 Midc Area , Waluj , Aurangabad, Maharashtra INDIA

Registration

FEI
3009278506
DUNS
864496135
Registered as
Wockhardt Limited
Registrant
WOCKHARDT LIMITED
Address
Plot No. E-1/1, M.I.D.C. Area, Shendra, Aurangabad, Maharashtra 431154, India (IND)
Operations
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.

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