Shalini Iyengar, MBBS

FDA inspection history across 2 sites, 2024 to 2025

1
Untitled letter: 1
Form 483

Every document, by year

Untitled letter
Form 483

The story so far

Built from the dates and citations on the documents themselves.

2024–25One Form 483 and one untitled letter, at Hexham and Hexham, United Kingdom.

Cited most

Across all Shalini Iyengar, MBBS observations on file

21 CFR 312.62(b)
Investigator recordkeeping and record retention
1

The complete Shalini Iyengar, MBBS file.

All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.

$198

The price of the documents, added to your cart together

Sites

Hexham, United Kingdom
One untitled letter · 2025
Latest: Untitled letter, Aug 5, 2025 →
Hexham
One Form 483 · 2024 · 1 observation
Latest: Form 483, May 24, 2024 →

Documents

2 on file, newest first

Date	Document	Location	Observations	Price
2025-08-05	Untitled letter Untitled letter	Hexham, United Kingdom	—	$99
2024-05-24	483 Form 483	Hexham	1	$99

Investigators on these documents

Kristin M. Abaonza (1)

FEI number 3025119430 · most recent document Aug 5, 2025

About Shalini Iyengar, MBBS

How many FDA Form 483s has Shalini Iyengar, MBBS received?

FDA Intel has 1 Form 483 on file for Shalini Iyengar, MBBS; the most recent is dated May 24, 2024.

When was Shalini Iyengar, MBBS last inspected by FDA?

The most recent FDA inspection document on file for Shalini Iyengar, MBBS is a Form 483 dated May 24, 2024, for the site in Hexham.

What did FDA cite at Shalini Iyengar, MBBS?

The regulations cited most in the observations on file for Shalini Iyengar, MBBS are 21 CFR 312.62(b) (Investigator recordkeeping and record retention), 1 time.

Has Shalini Iyengar, MBBS received an FDA untitled letter?

Yes. FDA Intel has 1 FDA untitled letter on file for Shalini Iyengar, MBBS; the most recent is dated Aug 5, 2025. An untitled letter is FDA's enforcement letter for violations that don't rise to warning-letter level.