SMC
Form 483 issued December 11, 2025
- Inspection
- Dec 8 – Dec 11, 2025
- Investigator
- Sunita Pandey
- Observations
- 3
- Pages
- 4
- FEI number
- 3011221234
In short: On December 11, 2025, FDA issued a Form 483 with 3 observations to SMC (FEI 3011221234) after an inspection that ran Dec 8 – Dec 11, 2025. The investigator was Sunita Pandey. Most observations concern cAPA and production & process controls.
At a glance
2 of 3 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Written MDR procedures have not been…
- 03
Specifically, justification documented. There is no agreement with suppliers to notify you of changes in the…
This inspection in context
Sunita Pandey
5 documents · 2022–2025
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in Massachusetts.
The firmSMC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SMC?
FDA listed 3 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected SMC?
Sunita Pandey is named on this Form 483, for the inspection of Dec 8 – Dec 11, 2025. Each investigator has a profile showing what they cite most.
When was SMC inspected by FDA?
The inspection ran Dec 8 – Dec 11, 2025, and the Form 483 is dated December 11, 2025.
How do I get the full Form 483 for SMC?
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.