Green Hills Health and Wellness Pharmacy, Inc.

Form 483 issued October 22, 2014 · Nashville, Tennessee

Inspection: Oct 14 – Oct 22, 2014
Investigators: Brandon C. Heitmeier· Justin N. Henson
Observations: 7
Pages: 4
FEI number: 1051570

In short: On October 22, 2014, FDA issued a Form 483 with 7 observations to Green Hills Health and Wellness Pharmacy, Inc. in Nashville, Tennessee (FEI 1051570) after an inspection that ran Oct 14 – Oct 22, 2014. The investigators were Brandon C. Heitmeier and Justin N. Henson. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

Facilities & equipment and laboratory controls account for 6 of 7 observations.

Facilities & equipment4

Laboratory controls2

Production1

What FDA observed

Preview: the opening words of each observation

01
21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
02
21 CFR 211.42(c)(10)(v)
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
03
21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system…
04
21 CFR 211.46(b)
Equipment for adequate control over air pressure is not provided when appropriate for the manufacture, processing…

3 more observations

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

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This inspection in context

The investigator

Brandon C. Heitmeier

12 documents · 2009–2022

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

The firm

Green Hills Health and Wellness Pharmacy, Inc. history

All 6 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.113(b)

See how FDA wrote the same problem up elsewhere.

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Response
The firm's reply to this 483Nov 11, 2014$199

Green Hills Health and Wellness Pharmacy, Inc. site file

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Questions about this 483

What did FDA find at Green Hills Health and Wellness Pharmacy, Inc.?

FDA listed 7 observations on this Form 483, mostly about facilities & equipment, laboratory controls 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 Green Hills Health and Wellness Pharmacy, Inc.?

Brandon C. Heitmeier and Justin N. Henson are named on this Form 483, for the inspection of Oct 14 – Oct 22, 2014. Each investigator has a profile showing what they cite most.

When was Green Hills Health and Wellness Pharmacy, Inc. inspected by FDA?

The inspection ran Oct 14 – Oct 22, 2014, and the Form 483 is dated October 22, 2014.

How do I get the full Form 483 for Green Hills Health and Wellness Pharmacy, Inc.?

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