SCA Phar maceutical s , LLC
Form 483 issued November 19, 2019 · Windsor, Connecticut
- Inspection
- Oct 8 – Nov 19, 2019
- Investigator
- Robert J. Martin
- Observations
- 2
- Pages
- 6
- FEI number
- 3013736415
In short: On November 19, 2019, FDA issued a Form 483 with 2 observations to SCA Phar maceutical s , LLC in Windsor, Connecticut (FEI 3013736415) after an inspection that ran Oct 8 – Nov 19, 2019. The investigator was Robert J. Martin. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.167 (1×)
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 and the failure of a batch…
- 02
Each batch of drug product required to be free of objectionable microorganisms is not tested…
This inspection in context
Robert J. Martin
29 documents · 2014–2023
Cites 211.113 (control of microbiological contamination) 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 211.192
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 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected SCA Phar maceutical s , LLC?
Robert J. Martin is named on this Form 483, for the inspection of Oct 8 – Nov 19, 2019. Each investigator has a profile showing what they cite most.
When was SCA Phar maceutical s , LLC inspected by FDA?
The inspection ran Oct 8 – Nov 19, 2019, and the Form 483 is dated November 19, 2019.
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.