Company
IndiaEmcure Pharmaceuticals Limited, Pune, India – FDA Inspections
Inspection records and compliance data for Emcure Pharmaceuticals Limited in Pune. 10 FDA inspections on record (3 OAI), 2 Form 483s, 1 warning letter, last inspected February 20, 2019.
Company Profile
This profile covers Emcure Pharmaceuticals Limited based in Pune, India.
FDA Inspection History
- FDA inspections
- 10
- OAI
- 3
- VAI
- 6
- NAI
- 1
- Form 483s
- 2
- Warning letters
- 1
First inspected February 19, 2009. Last inspected February 20, 2019.
Most cited issue areas
- Environmental Monitoring System2 inspections
- Investigations of discrepancies, failures2 inspections
- Procedures for sterile drug products2 inspections
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 20, 2019 | OAI | Human Drugs · Drug Quality Assurance | 1079858 |
| October 30, 2018 | NAI | Human Drugs · Bioresearch Monitoring | 1075227 |
| August 17, 2017 | OAI | Human Drugs · Drug Quality Assurance | 1023101 |
| February 4, 2015 | OAI | Human Drugs · Drug Quality Assurance | 912371 |
| February 7, 2014 | VAI | Human Drugs · Drug Quality Assurance | 867389 |
| April 26, 2013 | VAI | Human Drugs · Drug Quality Assurance | 834734 |
| September 18, 2012 | VAI | Human Drugs · Drug Quality Assurance | 802066 |
| November 22, 2010 | VAI | Human Drugs · Drug Quality Assurance | 715793 |
| November 10, 2009 | VAI | Human Drugs · Drug Quality Assurance | 633402 |
| February 19, 2009 | VAI | Human Drugs · Drug Quality Assurance | 583434 |
FDA documents
Warning Letters (1)
Other regulators (1)
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Emcure Pharmaceuticals Limited
FEI Number
3005151215
Address
Plot No. P-2, I.T.B.T. Park, Phase - II, MIDC, Hinjawadi, Pune, India
Country
India
ID: f9f57aff-9896-431c-b393-98180a923777