Emcure Pharmaceuticals Limited
Form 483 issued February 25, 2025 · Pune, India
- Inspection
- Feb 19 – Feb 25, 2025
- Investigator
- Kellia N. Hicks
- Observations
- 2
- Pages
- 4
- FEI number
- 3005782879
In short: On February 25, 2025, FDA issued a Form 483 with 2 observations to Emcure Pharmaceuticals Limited in Pune, Maharashtra (FEI 3005782879) after an inspection that ran Feb 19 – Feb 25, 2025. The investigator was Kellia N. Hicks. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.67 (1×) · 211.25 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to establish and follow adequate written procedures for cleaning and maintenance of equipment to prevent…
- 02
Failure to ensure proper documentation and…
This inspection in context
Kellia N. Hicks
28 documents · 2017–2025
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
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Emcure Pharmaceuticals Limited?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Emcure Pharmaceuticals Limited?
Kellia N. Hicks is named on this Form 483, for the inspection of Feb 19 – Feb 25, 2025. Each investigator has a profile showing what they cite most.
When was Emcure Pharmaceuticals Limited inspected by FDA?
The inspection ran Feb 19 – Feb 25, 2025, and the Form 483 is dated February 25, 2025.
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.