Invitro Research Solutions Private Ltd
Form 483 issued December 18, 2025 · Bengaluru, India
- Inspection
- Dec 15 – Dec 18, 2025
- Investigator
- Zachary L. Stamm
- Observations
- 1
- Pages
- 4
- FEI number
- 3014372507
In short: On December 18, 2025, FDA issued a Form 483 with 1 observation to Invitro Research Solutions Private Ltd in Bengaluru, Karnataka (FEI 3014372507) after an inspection that ran Dec 15 – Dec 18, 2025. The investigator was Zachary L. Stamm. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
This inspection in context
Zachary L. Stamm
13 documents · 2010–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Colorado.
The firmInvitro Research Solutions Private Ltd history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Invitro Research Solutions Private Ltd?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Invitro Research Solutions Private Ltd?
Zachary L. Stamm is named on this Form 483, for the inspection of Dec 15 – Dec 18, 2025. Each investigator has a profile showing what they cite most.
When was Invitro Research Solutions Private Ltd inspected by FDA?
The inspection ran Dec 15 – Dec 18, 2025, and the Form 483 is dated December 18, 2025.
How do I get the full Form 483 for Invitro Research Solutions Private Ltd?
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.