SMS PHARMACEUTICALS LIMITED, Unit-VII
Form 483 issued December 12, 2025 · Vizianagaram District, India
- Inspection
- Dec 8 – Dec 12, 2025
- Investigator
- Rowena S. Nguyen
- Observations
- 1
- Pages
- 1
- FEI number
- 3008654585
In short: On December 12, 2025, FDA issued a Form 483 with 1 observation to SMS PHARMACEUTICALS LIMITED, Unit-VII in Vizianagaram District, India (FEI 3008654585) after an inspection that ran Dec 8 – Dec 12, 2025. The investigator was Rowena S. Nguyen. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to ensure that all specifications are scientifically sound and appropriate to ensure that your API…
This inspection in context
Rowena S. Nguyen
12 documents · 2022–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in California.
The firmSMS PHARMACEUTICALS LIMITED, Unit-VII history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SMS PHARMACEUTICALS LIMITED, Unit-VII?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected SMS PHARMACEUTICALS LIMITED, Unit-VII?
Rowena S. Nguyen is named on this Form 483, for the inspection of Dec 8 – Dec 12, 2025. Each investigator has a profile showing what they cite most.
When was SMS PHARMACEUTICALS LIMITED, Unit-VII inspected by FDA?
The inspection ran Dec 8 – Dec 12, 2025, and the Form 483 is dated December 12, 2025.
How do I get the full Form 483 for SMS PHARMACEUTICALS LIMITED, Unit-VII?
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.