Almon Healthcare Private Limited
Form 483 issued February 13, 2026
- Inspection
- Feb 9 – Feb 13, 2026
- Investigator
- Paranthaman Senthamarai Kannan
- Observations
- 11
- Pages
- 10
- FEI number
- 3030509366
In short: On February 13, 2026, FDA issued a Form 483 with 11 observations to Almon Healthcare Private Limited (FEI 3030509366) after an inspection that ran Feb 9 – Feb 13, 2026. The investigator was Paranthaman Senthamarai Kannan. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Laboratory controls and facilities & equipment account for 8 of 11 observations.
Most cited: 21 CFR 211.166 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure of your quality unit to exercise its responsibility to ensure the active pharmaceutical ingredient (API)…
- 02
Your firm failed to use validated…
- 03
Failure to ensure that all specifications are scientifically sound and appropriate to ensure that your raw…
- 04
Your firm failed to exercise sufficient controls over computerized systems to prevent unauthorized access or changes…
This inspection in context
Paranthaman Senthamarai Kannan
4 documents · 2024–2026
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in India.
The firmAlmon Healthcare Private 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 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Almon Healthcare Private Limited?
FDA listed 11 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Almon Healthcare Private Limited?
Paranthaman Senthamarai Kannan is named on this Form 483, for the inspection of Feb 9 – Feb 13, 2026. Each investigator has a profile showing what they cite most.
When was Almon Healthcare Private Limited inspected by FDA?
The inspection ran Feb 9 – Feb 13, 2026, and the Form 483 is dated February 13, 2026.
How do I get the full Form 483 for Almon Healthcare Private 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.