Site records / Maharashtra / FEI 3004995645
Lupin LimitedChhatrapati Sambhajinagar, Maharashtra
FDA-registered drug establishment in Chhatrapati Sambhajinagar, Maharashtra: manufacture, pack. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 5
- Last inspection
- Mar 2024 · VAI
- Warning letters to this FEI
- 0
- Import alerts at this address
- 0
- US border refusals, 2 years
- 1
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.
- 15 Mar 2024VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 14 Feb 2020NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 3 Apr 2015VAI · Voluntary Action IndicatedDrug Quality Assurance · 2 citations posted
- 27 Jul 2012NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 5 Nov 2009NAI · No Action IndicatedDrug Quality Assurance · no citations posted
Warning letters and compliance actions
- 27 Sep 2022Warning letter to Lupin Limited SourceCGMP/Active Pharmaceutical Ingredient (API)/Adulterated · issued to the firm name; FDA does not tie it to this FEI
Import alerts in force
No listing in force under this firm's name.
Form 483s released by FDA
- 15 May 2019Form 483 · 2 pages Source
Other registered sites of Lupin
- Lupin LimitedMandideep, Madhya Pradesh
- Lupin LimitedTarapur, Maharashtra
- Lupin LimitedSalcette, Goa
- Lupin LimitedPithampur, Madhya Pradesh
- Lupin LimitedMandideep, Madhya Pradesh
- Lupin LimitedPithampur, Madhya Pradesh
- Lupin LimitedDhar, Madhya Pradesh
- Lupin LimitedNagpur, Maharashtra
- Lupin LimitedNagpur, Maharashtra
- Lupin Manufacturing Solutions LimitedVadodara, Gujarat
- Lupin Manufacturing Solutions LimitedAnakapalli District, Andhra Pradesh
Registration
- FEI
- 3004995645
- DUNS
- 862272739
- Registered as
- LUPIN LIMITED
- Registrant
- LUPIN LIMITED
- Address
- A 28-1, MIDC Industrial Area, Chikalthana, Chhatrapati Sambhajinagar, Maharashtra 431210, India (IND)
- Operations
- MANUFACTURE, PACK
- 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.