Green Hills Health and Wellness Pharmacy, Inc.
Form 483 issued June 30, 2016 · Nashville, Tennessee
- Inspection
- Jun 14 – Jun 30, 2016
- Investigators
- Meocha V. Whaley· Zada L. Giles
- Observations
- 1
- Pages
- 1
- FEI number
- 1051570
In short: On June 30, 2016, FDA issued a Form 483 with 1 observation to Green Hills Health and Wellness Pharmacy, Inc. in Nashville, Tennessee (FEI 1051570) after an inspection that ran Jun 14 – Jun 30, 2016. The investigators were Meocha V. Whaley and Zada L. Giles. Most observations concern materials; the most-cited regulation is 21 CFR 211.94 (drug product containers and closures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.94 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Drug product containers were not sterilized and processed to remove pyrogenic properties to assure that they…
This inspection in context
Meocha V. Whaley
1 document · 2016
Cites 211.94 (drug product containers and closures) more than any other section. Most of their documents are for sites in Tennessee.
The firmGreen 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 483sOther sites cited under 211.94
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Green Hills Health and Wellness Pharmacy, Inc.?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.94 (drug product containers and closures). The opening words of each observation are shown on this page.
Who inspected Green Hills Health and Wellness Pharmacy, Inc.?
Meocha V. Whaley and Zada L. Giles are named on this Form 483, for the inspection of Jun 14 – Jun 30, 2016. 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 Jun 14 – Jun 30, 2016, and the Form 483 is dated June 30, 2016.
How do I get the full Form 483 for Green Hills Health and Wellness Pharmacy, Inc.?
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.