Site records / Gujarat / FEI 3004610460
Baxter Pharmaceuticals India Private LimitedAhmedabad, Gujarat
FDA-registered drug establishment in Ahmedabad, Gujarat: analysis, label, manufacture, pack, sterilize. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 9
- Last inspection
- Jan 2023 · OAI
- Warning letters to this FEI
- 3
- 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
9 FDA inspections of this FEI, by end date; 9 with a posted classification.
- 27 Jan 2023OAI · Official Action IndicatedDrug Quality Assurance · 9 citations posted
- 17 May 2022VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 4 Aug 2017OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
- 26 Aug 2016VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 11 May 2015VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 18 Oct 2013VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 2 Mar 2012VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 16 Jun 2010OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
- 12 Nov 2009VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
Warning letters and compliance actions
- 25 Jul 2023Warning Letter · CDER SourceCGMP/Finished Pharmaceuticals/Adulterated
- 5 Jul 2018Warning Letter · CDER
- 1 Nov 2010Warning Letter · CDER
- 19 Dec 2013Warning letter to Baxter Healthcare Corporation SourceCGMP/QSR/Medical Devices/Adulterated · issued to the firm name; FDA does not tie it to this FEI
- 31 May 2013Warning letter to Baxter Healthcare Corporation SourceCGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated · issued to the firm name; FDA does not tie it to this FEI
- 1 Apr 2013Warning letter to Baxter Healthcare Corporation SourceQuality System Regulation for Medical Devices/Adulterated/Misbranded · issued to the firm name; FDA does not tie it to this FEI
- 20 Jan 2011Warning letter to Baxter Healthcare Corporation SourceCGMP Regulations for Finished Pharmaceuticals/Adulterated · issued to the firm name; FDA does not tie it to this FEI
- 3 Aug 2010Warning letter to Baxter International Inc. SourceMisleading Efficacy Claim · issued to the firm name; FDA does not tie it to this FEI
- 3 Jun 2010Warning letter to Baxter Healthcare Corporation SourceMedical Device Reporting (MDR) Regulation/Adulterated · issued to the firm name; FDA does not tie it to this FEI
- 15 Jan 2010Warning letter to Baxter Biosciences SourceCGMP Deviations · 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
Registration
- FEI
- 3004610460
- DUNS
- 918603338
- Registered as
- BAXTER PHARMACEUTICALS INDIA PRIVATE LIMITED
- Registrant
- Baxter Healthcare Corporation
- Address
- Village Vasana-Chacharwadi, Taluka Sanand, Ahmedabad, Gujarat 382213, India (IND)
- Operations
- ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE
- 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.