SCA Phar maceutical s , LLC
Form 483 issued March 13, 2026 · Windso r, Connecticut
- Inspection
- Feb 17 – Mar 13, 2026
- Investigator
- Simone E. Pitts
- Observations
- 3
- Pages
- 6
- FEI number
- 3013736415
In short: On March 13, 2026, FDA issued a Form 483 with 3 observations to SCA Phar maceutical s , LLC in Windso r, Connecticut (FEI 3013736415) after an inspection that ran Feb 17 – Mar 13, 2026. The investigator was Simone E. Pitts. Most observations concern production and quality system.
At a glance
Production and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
This inspection in context
Simone E. Pitts
18 documents · 2014–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Illinois.
The firmSCA Phar maceutical s , LLC history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SCA Phar maceutical s , LLC?
FDA listed 3 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected SCA Phar maceutical s , LLC?
Simone E. Pitts is named on this Form 483, for the inspection of Feb 17 – Mar 13, 2026. Each investigator has a profile showing what they cite most.
When was SCA Phar maceutical s , LLC inspected by FDA?
The inspection ran Feb 17 – Mar 13, 2026, and the Form 483 is dated March 13, 2026.
How do I get the full Form 483 for SCA Phar maceutical s , LLC?
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.