SCA Phar maceutical s , LLC
Form 483 issued December 20, 2024 · Windsor, Connecticut
- Inspection
- Dec 2 – Dec 20, 2024
- Investigators
- Jazmine N. Brown· Samir C. Gala
- Observations
- 7
- Pages
- 11
- FEI number
- 3013736415
In short: On December 20, 2024, FDA issued a Form 483 with 7 observations to SCA Phar maceutical s , LLC in Windsor, Connecticut (FEI 3013736415) after an inspection that ran Dec 2 – Dec 20, 2024. The investigators were Jazmine N. Brown and Samir C. Gala. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 6 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 03
Written procedures are not for the cleaning and maintenance of equipment, including utensils, used in the…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Jazmine N. Brown
14 documents · 2022–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Pennsylvania.
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 211.192
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 7 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected SCA Phar maceutical s , LLC?
Jazmine N. Brown and Samir C. Gala are named on this Form 483, for the inspection of Dec 2 – Dec 20, 2024. Each investigator has a profile showing what they cite most.
When was SCA Phar maceutical s , LLC inspected by FDA?
The inspection ran Dec 2 – Dec 20, 2024, and the Form 483 is dated December 20, 2024.
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.