Intrathecal Compounding Specialists, LLC

Form 483 issued November 17, 2017 · Scott, Louisiana

Inspection: Nov 6 – Nov 17, 2017
Investigator: Claire M. Minden
Observations: 14
Pages: 6
FEI number: 3006372310

In short: On November 17, 2017, FDA issued a Form 483 with 14 observations to Intrathecal Compounding Specialists, LLC in Scott, Louisiana (FEI 3006372310) after an inspection that ran Nov 6 – Nov 17, 2017. The investigator was Claire M. Minden. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).

At a glance

Observations span 3 systems, led by production.

Production2

Facilities & equipment1

Laboratory controls1

Other10

Most cited: FDCA 501(a)(2)(A) (10×) · 211.113 (2×)

What FDA observed

Preview: the opening words of each observation

01
FDCA 501(a)(2)(A)
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was…
02
FDCA 501(a)(2)(A)
You produced highly potent drugs without providing adequate segregation, cleaning of work surfaces and cleaning of…
03
FDCA 501(a)(2)(A)
Personnel touched equipment or other surfaces located outside of the ISO 5 classified aseptic processing area…
04
FDCA 501(a)(2)(A)
Personnel donned gowning apparel improperly, in a way that may have caused the gowning…

10 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

The investigator

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 firm

Intrathecal Compounding Specialists, LLC history

All 5 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.113

See how FDA wrote the same problem up elsewhere.

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Response
The firm's reply to this 483Jan 8, 2018$199

Intrathecal Compounding Specialists, LLC site file

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Questions about this 483

What did FDA find at Intrathecal Compounding Specialists, LLC?

FDA listed 14 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). 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 Nov 6 – Nov 17, 2017. Each investigator has a profile showing what they cite most.

When was Intrathecal Compounding Specialists, LLC inspected by FDA?

The inspection ran Nov 6 – Nov 17, 2017, and the Form 483 is dated November 17, 2017.

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.