SCA Phar maceutical s , LLC
Form 483 issued February 20, 2024 · Windsor, Connecticut
- Inspection
- Feb 2 – Feb 20, 2024
- Investigators
- Jazmine N. Brown· Samir C. Gala
- Observations
- 7
- Pages
- 11
- FEI number
- 3013736415
In short: On February 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 Feb 2 – Feb 20, 2024. The investigators were Jazmine N. Brown and Samir C. Gala. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Production and facilities & equipment account for 6 of 7 observations.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has…
- 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 diug 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 211.67
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 most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). 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 Feb 2 – Feb 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 Feb 2 – Feb 20, 2024, and the Form 483 is dated February 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.