Emcure Pharmaceuticals Limited
Form 483 issued February 16, 2023 · Ahmedabad, India
- Inspection
- Feb 7 – Feb 16, 2023
- Investigator
- Kellia N. Hicks
- Observations
- 5
- Pages
- 4
- FEI number
- 3014595023
In short: On February 16, 2023, FDA issued a Form 483 with 5 observations to Emcure Pharmaceuticals Limited in Ahmedabad, Gujarat (FEI 3014595023) after an inspection that ran Feb 7 – Feb 16, 2023. The investigator was Kellia N. Hicks. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
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
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Emcure Pharmaceuticals Limited?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, quality system and production. 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 7 – Feb 16, 2023. Each investigator has a profile showing what they cite most.
When was Emcure Pharmaceuticals Limited inspected by FDA?
The inspection ran Feb 7 – Feb 16, 2023, and the Form 483 is dated February 16, 2023.
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.