SCA Phar maceutical s , LLC
Form 483 issued October 20, 2023 · Windsor, Connecticut
- Inspection
- Sep 18 – Oct 20, 2023
- Investigators
- John P. Mistler· Jonah S. Ufferfilge
- Observations
- 10
- Pages
- 15
- FEI number
- 3013736415
In short: On October 20, 2023, FDA issued a Form 483 with 10 observations to SCA Phar maceutical s , LLC in Windsor, Connecticut (FEI 3013736415) after an inspection that ran Sep 18 – Oct 20, 2023. The investigators were John P. Mistler and Jonah S. Ufferfilge. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 7 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
This inspection in context
John P. Mistler
15 documents · 2015–2023
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Massachusetts.
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 211.22(a)
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 10 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected SCA Phar maceutical s , LLC?
John P. Mistler and Jonah S. Ufferfilge are named on this Form 483, for the inspection of Sep 18 – Oct 20, 2023. Each investigator has a profile showing what they cite most.
When was SCA Phar maceutical s , LLC inspected by FDA?
The inspection ran Sep 18 – Oct 20, 2023, and the Form 483 is dated October 20, 2023.
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.