SCA Pharmaceuticals, LLC
Form 483 issued October 30, 2025 · Little Roc k, Arkansas
- Inspection
- Oct 20 – Oct 30, 2025
- Investigator
- Demario L. Walls
- Observations
- 4
- Pages
- 5
- FEI number
- 3010683157
In short: On October 30, 2025, FDA issued a Form 483 with 4 observations to SCA Pharmaceuticals, LLC in Little Roc k, Arkansas (FEI 3010683157) after an inspection that ran Oct 20 – Oct 30, 2025. The investigator was Demario L. Walls. Most observations concern production and facilities & equipment.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
This inspection in context
Demario L. Walls
18 documents · 2020–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SCA Pharmaceuticals, LLC?
FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected SCA Pharmaceuticals, LLC?
Demario L. Walls is named on this Form 483, for the inspection of Oct 20 – Oct 30, 2025. Each investigator has a profile showing what they cite most.
When was SCA Pharmaceuticals, LLC inspected by FDA?
The inspection ran Oct 20 – Oct 30, 2025, and the Form 483 is dated October 30, 2025.
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.