SCA Pharmaceuticals, LLC
Form 483 issued September 29, 2017 · Little Rock, Arkansas
- Inspection
- Sep 25 – Sep 29, 2017
- Investigators
- Claire M. Minden· Ninmy Mathews
- Observations
- 6
- Pages
- 6
- FEI number
- 3010683157
In short: On September 29, 2017, FDA issued a Form 483 with 6 observations to SCA Pharmaceuticals, LLC in Little Rock, Arkansas (FEI 3010683157) after an inspection that ran Sep 25 – Sep 29, 2017. The investigators were Claire M. Minden and Ninmy Mathews. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
This inspection in context
Claire M. Minden
26 documents · 2013–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Louisiana.
The firmSCA Pharmaceuticals, LLC history
All 8 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SCA Pharmaceuticals, LLC?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected SCA Pharmaceuticals, LLC?
Claire M. Minden and Ninmy Mathews are named on this Form 483, for the inspection of Sep 25 – Sep 29, 2017. Each investigator has a profile showing what they cite most.
When was SCA Pharmaceuticals, LLC inspected by FDA?
The inspection ran Sep 25 – Sep 29, 2017, and the Form 483 is dated September 29, 2017.
How do I get the full Form 483 for SCA Pharmaceuticals, 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.