Shalini Iyengar, MBBS
Form 483 issued May 24, 2024 · Hexham
- Inspection
- May 20 – May 24, 2024
- Investigator
- Kristin M. Abaonza
- Observations
- 1
- Pages
- 3
- FEI number
- 3025119430
In short: On May 24, 2024, FDA issued a Form 483 with 1 observation to Shalini Iyengar, MBBS in Hexham (FEI 3025119430) after an inspection that ran May 20 – May 24, 2024. The investigator was Kristin M. Abaonza. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 312.62 (investigator recordkeeping and record retention).
At a glance
1 of 1 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 312.62(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Failure to prepare or maintain adequate and accurate case histories with respect to observations and data…
This inspection in context
Kristin M. Abaonza
12 documents · 2015–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmShalini Iyengar, MBBS history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 312.62(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Shalini Iyengar, MBBS?
FDA listed 1 observation on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 312.62 (investigator recordkeeping and record retention). The opening words of each observation are shown on this page.
Who inspected Shalini Iyengar, MBBS?
Kristin M. Abaonza is named on this Form 483, for the inspection of May 20 – May 24, 2024. Each investigator has a profile showing what they cite most.
When was Shalini Iyengar, MBBS inspected by FDA?
The inspection ran May 20 – May 24, 2024, and the Form 483 is dated May 24, 2024.
How do I get the full Form 483 for Shalini Iyengar, MBBS?
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