SCA Pharmaceuticals, LLC
Form 483 issued May 17, 2023 · Little Rock, Arkansas
- Inspection
- May 2 – May 17, 2023
- Investigators
- Lisa R. Hilliard· Margaret M. Annes· Megan Ziegler
- Observations
- 4
- Pages
- 6
- FEI number
- 3010683157
In short: On May 17, 2023, FDA issued a Form 483 with 4 observations to SCA Pharmaceuticals, LLC in Little Rock, Arkansas (FEI 3010683157) after an inspection that ran May 2 – May 17, 2023. The investigators were Lisa R. Hilliard, Margaret M. Annes and Megan Ziegler. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
3 of 4 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 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 and the failure of a batch…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Lisa R. Hilliard
15 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ohio.
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 4 observations on this Form 483, mostly about facilities & equipment 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?
Lisa R. Hilliard, Margaret M. Annes and Megan Ziegler are named on this Form 483, for the inspection of May 2 – May 17, 2023. Each investigator has a profile showing what they cite most.
When was SCA Pharmaceuticals, LLC inspected by FDA?
The inspection ran May 2 – May 17, 2023, and the Form 483 is dated May 17, 2023.
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.