SI Group, Inc.
Form 483 issued January 17, 2025 · Orangeburg, South Carolina
- Observations
- 3
- Pages
- 8
- FEI number
- 3011012288
In short: On January 17, 2025, FDA issued a Form 483 with 3 observations to SI Group, Inc. in Orangeburg, South Carolina (FEI 3011012288). Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Scales used in the Packaging Operation are not…
- 02
There is no proper second verification…
- 03
Areas of Packaging Room clean…
This inspection in context
Questions about this 483
What did FDA find at SI Group, Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
When was SI Group, Inc. inspected by FDA?
This Form 483 is dated January 17, 2025.
How do I get the full Form 483 for SI Group, Inc.?
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.