SCA Pharmaceuticals, LLC
Form 483 issued November 7, 2019 · Little Rock, Arkansas
- Inspection
- Oct 28 – Nov 7, 2019
- Investigator
- Claire M. Minden
- Observations
- 6
- Pages
- 3
- FEI number
- 3010683157
In short: On November 7, 2019, FDA issued a Form 483 with 6 observations to SCA Pharmaceuticals, LLC in Little Rock, Arkansas (FEI 3010683157) after an inspection that ran Oct 28 – Nov 7, 2019. The investigator was Claire M. Minden. Most observations concern quality system and laboratory controls.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
The results of the examination of the packaged and labeled products were not documented in the…
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 211.167
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 quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected SCA Pharmaceuticals, LLC?
Claire M. Minden is named on this Form 483, for the inspection of Oct 28 – Nov 7, 2019. Each investigator has a profile showing what they cite most.
When was SCA Pharmaceuticals, LLC inspected by FDA?
The inspection ran Oct 28 – Nov 7, 2019, and the Form 483 is dated November 7, 2019.
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.