SCA Phar maceutical s , LLC
Form 483 issued March 5, 2018 · Windsor, Connecticut
- Inspection
- Feb 12 – Mar 5, 2018
- Investigators
- Dien N. Nguyen· Jonathan G. Matrisciano
- Observations
- 13
- Pages
- 7
- FEI number
- 3013736415
In short: On March 5, 2018, FDA issued a Form 483 with 13 observations to SCA Phar maceutical s , LLC in Windsor, Connecticut (FEI 3013736415) after an inspection that ran Feb 12 – Mar 5, 2018. The investigators were Dien N. Nguyen and Jonathan G. Matrisciano. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.113 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
On 2/20/2018 we observed the compounding te<;hnici:m touching…
- 03
On 2/14/2018, we observed heavily soiled tacky mats located in the unclassified area in front of…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Dien N. Nguyen
6 documents · 2016–2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Connecticut.
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 13 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected SCA Phar maceutical s , LLC?
Dien N. Nguyen and Jonathan G. Matrisciano are named on this Form 483, for the inspection of Feb 12 – Mar 5, 2018. Each investigator has a profile showing what they cite most.
When was SCA Phar maceutical s , LLC inspected by FDA?
The inspection ran Feb 12 – Mar 5, 2018, and the Form 483 is dated March 5, 2018.
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.