Intrathecal Compounding Specialists, LLC
Form 483 issued August 19, 2021 · Scot t, Louisiana
- Inspection
- Aug 9 – Aug 19, 2021
- Investigator
- Claire M. Minden
- Observations
- 3
- Pages
- 3
- FEI number
- 3006372310
In short: On August 19, 2021, FDA issued a Form 483 with 3 observations to Intrathecal Compounding Specialists, LLC in Scot t, Louisiana (FEI 3006372310) after an inspection that ran Aug 9 – Aug 19, 2021. The investigator was Claire M. Minden.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was…
- 02FDCA 501(a)(2)(A)
Disinfecting agents and cleaning pads and cleaning wipes used in the ISO 5 classified aseptic processing…
- 03FDCA 501(a)(2)(A)
Disinfectant contact time (also kno·wn as "dwell time") and coverage of the item being disinfected were…
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 483sMore form 483s
Browse other documents of this type.
Questions about this 483
What did FDA find at Intrathecal Compounding Specialists, LLC?
FDA listed 3 observations on this Form 483. 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 Aug 9 – Aug 19, 2021. Each investigator has a profile showing what they cite most.
When was Intrathecal Compounding Specialists, LLC inspected by FDA?
The inspection ran Aug 9 – Aug 19, 2021, and the Form 483 is dated August 19, 2021.
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.