The Wellness Center Pharmacy, Inc., dba Designer Drugs
Form 483 issued May 28, 2015 · Chattanooga, Tennessee
- Inspection
- May 18 – May 28, 2015
- Investigator
- Brandon C. Heitmeier
- Observations
- 13
- Pages
- 6
- FEI number
- 3004578635
In short: On May 28, 2015, FDA issued a Form 483 with 13 observations to The Wellness Center Pharmacy, Inc., dba Designer Drugs in Chattanooga, Tennessee (FEI 3004578635) after an inspection that ran May 18 – May 28, 2015. The investigator was Brandon C. Heitmeier. 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 10 of 13 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Clothing of personnel engaged in the manufacturing, processing, and packing of drug products is not appropriate…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
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 firmThe Wellness Center Pharmacy, Inc., dba Designer Drugs history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at The Wellness Center Pharmacy, Inc., dba Designer Drugs?
FDA listed 13 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 The Wellness Center Pharmacy, Inc., dba Designer Drugs?
Brandon C. Heitmeier is named on this Form 483, for the inspection of May 18 – May 28, 2015. Each investigator has a profile showing what they cite most.
When was The Wellness Center Pharmacy, Inc., dba Designer Drugs inspected by FDA?
The inspection ran May 18 – May 28, 2015, and the Form 483 is dated May 28, 2015.
How do I get the full Form 483 for The Wellness Center Pharmacy, Inc., dba Designer Drugs?
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