Montana Compounding Pharmacy and Wellness Center

Form 483 issued May 8, 2015 · Missoula, Montana

Inspection: Apr 28 – May 8, 2015
Investigators: Barbara J. Breithaupt· Gary C. Pecic· Tracy K. Li
Observations: 15
Pages: 14
FEI number: 3011501377

In short: On May 8, 2015, FDA issued a Form 483 with 15 observations to Montana Compounding Pharmacy and Wellness Center in Missoula, Montana (FEI 3011501377) after an inspection that ran Apr 28 – May 8, 2015. The investigators were Barbara J. Breithaupt, Gary C. Pecic, Tracy K. Li and Tracy K. Ll. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

Facilities & equipment and production account for 12 of 15 observations.

Facilities & equipment7

Production5

Materials1

Laboratory controls1

Other1

Most cited: 21 CFR 211.42 (4×) · 211.56 (2×)

What FDA observed

Preview: the opening words of each observation

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

01
21 CFR 211.84
Each lot of a drug component that is liable to microbiological contamination that is objectionable in…
02
21 CFR 211.113
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
03
21 CFR 211.42
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
04
21 CFR 211.42 21 CFR 211.56
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…

11 more observations

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

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This inspection in context

The investigator

Barbara J. Breithaupt

3 documents · 2014–2021

Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Montana.

The firm

Montana Compounding Pharmacy and Wellness Center history

All 2 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.42

See how FDA wrote the same problem up elsewhere.

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Form 483 from this inspectionMay 15, 2015$99

Montana Compounding Pharmacy and Wellness Center site file

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Questions about this 483

What did FDA find at Montana Compounding Pharmacy and Wellness Center?

FDA listed 15 observations on this Form 483, mostly about facilities & equipment, production and materials. 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 Montana Compounding Pharmacy and Wellness Center?

Barbara J. Breithaupt, Gary C. Pecic, Tracy K. Li and Tracy K. Ll are named on this Form 483, for the inspection of Apr 28 – May 8, 2015. Each investigator has a profile showing what they cite most.

When was Montana Compounding Pharmacy and Wellness Center inspected by FDA?

The inspection ran Apr 28 – May 8, 2015, and the Form 483 is dated May 8, 2015.

How do I get the full Form 483 for Montana Compounding Pharmacy and Wellness Center?

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.