Site records / Maharashtra / FEI 3002806702
Cipla LimitedPune, Maharashtra
FDA-registered drug establishment in Pune, Maharashtra: analysis, api manufacture, label, manufacture, pack. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 7
- Last inspection
- May 2024 · VAI
- Warning letters to this FEI
- 0
- Import alerts at this address
- 1 of 3 under the name
- US border refusals, 2 years
- 2
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
7 FDA inspections of this FEI, by end date; 7 with a posted classification.
- 8 May 2024VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 20 Mar 2019VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 30 Nov 2018NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 9 Dec 2016VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 23 May 2014NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 1 Dec 2011VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 26 Mar 2009VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
Warning letters and compliance actions
- 17 Nov 2023Warning letter to Cipla 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.
- 18 Oct 2010Import alert 66-66 · Published address is this site SourcePublished address: Plots D-7, D-22, D-27 , M.I.D.C. Industrial Area, Taluka-Daund , Kurkumbh Village, Dist. Pune, Maharashtra INDIA
- 14 Mar 2017Import alert 66-41 · Published address is not this site SourceDetention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.Published address: Khasra No. 509/1-2 & 520 , Vii-Bhagwanpur , Bhagwanpur, Uttaranchal INDIA
- 9 Oct 2013Import alert 66-66 · Published address is another site of this firm SourcePublished address: Patalganga Industrial Area , Plot No A-2, A-33, A-37/2/2, A-42 , Raigad, Maharashtra INDIA
Form 483s released by FDA
- 8 May 2024Form 483 · 1 page Source
Other registered sites of Cipla
- Cipla LimitedBengaluru, Karnataka
- Cipla LimitedRaigad, Maharashtra
- Cipla LimitedSalcette, Goa
- Cipla LimitedBengaluru, Karnataka
- Cipla LimitedIndore, Madhya Pradesh
Registration
- FEI
- 3002806702
- DUNS
- 917066446
- Registered as
- CIPLA LIMITED
- Registrant
- CIPLA LIMITED
- Address
- Plot D-7, D-22, D-27 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune, Maharashtra 413802, India (IND)
- Operations
- ANALYSIS, API MANUFACTURE, LABEL, 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.