MSLS LLC dba The Medicine Shoppe

Form 483 issued September 28, 2022 · Lees Su.llllWt, Missouri

Inspection
Sep 26 – Sep 28, 2022
Observations
3
Pages
5
FEI number
3012814943

In short: On September 28, 2022, FDA issued a Form 483 with 3 observations to MSLS LLC dba The Medicine Shoppe in Lees Su.llllWt, Missouri (FEI 3012814943) after an inspection that ran Sep 26 – Sep 28, 2022. The investigators were Jill Tillman and Lauren N. Howard. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).

At a glance

2 of 3 observations on this 483 concern facilities & equipment.

Facilities & equipment2
Other1

Most cited: 21 CFR 211.67 (2×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01

    Non-microbial contamination was observed…

  2. 02

    You produced hazardous drugs without providing adequate containment, segregation, cleaning of work surfaces and cleaning of…

  3. 03

    You used a non-pharmaceutical grade component in the formulation…

The full 483

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

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This inspection in context

Questions about this 483

What did FDA find at MSLS LLC dba The Medicine Shoppe?

FDA listed 3 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.

Who inspected MSLS LLC dba The Medicine Shoppe?

Jill Tillman and Lauren N. Howard are named on this Form 483, for the inspection of Sep 26 – Sep 28, 2022. Each investigator has a profile showing what they cite most.

When was MSLS LLC dba The Medicine Shoppe inspected by FDA?

The inspection ran Sep 26 – Sep 28, 2022, and the Form 483 is dated September 28, 2022.

How do I get the full Form 483 for MSLS LLC dba The Medicine Shoppe?

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