Intrathecal Compounding Specialists, LLC
Form 483 issued February 14, 2019 · Scott, Louisiana
- Inspection
- Feb 6 – Feb 14, 2019
- Investigator
- Claire M. Minden
- Observations
- 5
- Pages
- 2
- FEI number
- 3006372310
In short: On February 14, 2019, FDA issued a Form 483 with 5 observations to Intrathecal Compounding Specialists, LLC in Scott, Louisiana (FEI 3006372310) after an inspection that ran Feb 6 – Feb 14, 2019. The investigator was Claire M. Minden. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The ISO classified area underwent a change in air equipment that (b)(4) produce and distribute sterile…
- 02
Inadequate pressure differentials between higher quality air room and lower quality…
- 03
The use of sporicidal agents in the cleanrooms and ISO 5 area…
- 04
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities…
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 firmIntrathecal Compounding Specialists, LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Intrathecal Compounding Specialists, LLC?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment and production. 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 Intrathecal Compounding Specialists, LLC?
Claire M. Minden is named on this Form 483, for the inspection of Feb 6 – Feb 14, 2019. Each investigator has a profile showing what they cite most.
When was Intrathecal Compounding Specialists, LLC inspected by FDA?
The inspection ran Feb 6 – Feb 14, 2019, and the Form 483 is dated February 14, 2019.
How do I get the full Form 483 for Intrathecal Compounding Specialists, 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.