Emcure Pharmaceuticals Limited

Form 483FOIA Uncovered

Pune, -, IndiaFEI 3005151215Issued February 20, 2019

View FDA's Record for This Firm

Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3005151215.

Observations6

Issue DateFebruary 20, 2019

Status1 Related Warning Letter

Related Inspections10

Establishment Details

Firm: Emcure Pharmaceuticals Limited
Location: Pune, -, India
FEI Number: 3005151215
Product Type: Drugs
Issue Date: February 20, 2019
Country: India

Inspection History, 2009 to 2019

NAI1

VAI6

OAI3

NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.

Act on This Form 483

FDA Inspection ReadinessSee how your operations would hold up to the same scrutiny.CAPA & InvestigationsScore how you would investigate and close findings like these.Talk to a SpecialistWalk through these observations with a ComplianceQuest expert.

Emcure Pharmaceuticals Limited FDA Form 483, Pune, February 20, 2019