Emcure Pharmaceuticals Limited
Form 483 issued February 20, 2019 · Hinjwadi, India
- Inspection
- Feb 11 – Feb 20, 2019
- Investigators
- Jose E. Melendez· Linda F. Murphy· Walden H. Lee
- Observations
- 1
- Pages
- 11
- FEI number
- 3005151215
In short: On February 20, 2019, FDA issued a Form 483 with 1 observation to Emcure Pharmaceuticals Limited in Hinjwadi, India (FEI 3005151215) after an inspection that ran Feb 11 – Feb 20, 2019. The investigators were Jose E. Melendez, Linda F. Murphy and Walden H. Lee. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Jose E. Melendez
44 documents · 2001–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmEmcure Pharmaceuticals Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Emcure Pharmaceuticals Limited?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Emcure Pharmaceuticals Limited?
Jose E. Melendez, Linda F. Murphy and Walden H. Lee are named on this Form 483, for the inspection of Feb 11 – Feb 20, 2019. Each investigator has a profile showing what they cite most.
When was Emcure Pharmaceuticals Limited inspected by FDA?
The inspection ran Feb 11 – Feb 20, 2019, and the Form 483 is dated February 20, 2019.
How do I get the full Form 483 for Emcure Pharmaceuticals Limited?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.