Emcure Pharmaceuticals Limited
Form 483 issued May 15, 2026 · Ahmedabad, India
- Inspection
- May 6 – May 15, 2026
- Investigators
- Brandy N. Lepage· Jessica S. Estriplet
- Observations
- 1
- Pages
- 9
- FEI number
- 3014595023
In short: On May 15, 2026, FDA issued a Form 483 with 1 observation to Emcure Pharmaceuticals Limited in Ahmedabad, Gujarat (FEI 3014595023) after an inspection that ran May 6 – May 15, 2026. The investigators were Brandy N. Lepage and Jessica S. Estriplet. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.63 (equipment design, size, and location).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.63 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Brandy N. Lepage
31 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmEmcure Pharmaceuticals Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.63
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 facilities & equipment. The most-cited regulation is 21 CFR 211.63 (equipment design, size, and location). The opening words of each observation are shown on this page.
Who inspected Emcure Pharmaceuticals Limited?
Brandy N. Lepage and Jessica S. Estriplet are named on this Form 483, for the inspection of May 6 – May 15, 2026. Each investigator has a profile showing what they cite most.
When was Emcure Pharmaceuticals Limited inspected by FDA?
The inspection ran May 6 – May 15, 2026, and the Form 483 is dated May 15, 2026.
How do I get the full Form 483 for Emcure Pharmaceuticals Limited?
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