The Wellness Center Pharmacy, Inc., dba Designer Drugs
Form 483 issued December 22, 2017 · Chattanooga, Tennessee
- Inspection
- Dec 12 – Dec 22, 2017
- Investigators
- Brian J. Hettler· Luis A. Tovar
- Observations
- 3
- Pages
- 2
- FEI number
- 3004578635
In short: On December 22, 2017, FDA issued a Form 483 with 3 observations to The Wellness Center Pharmacy, Inc., dba Designer Drugs in Chattanooga, Tennessee (FEI 3004578635) after an inspection that ran Dec 12 – Dec 22, 2017. The investigators were Brian J. Hettler and Luis A. Tovar. Most observations concern facilities & equipment and production.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Non-microbial contamination was observed…
- 02
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities…
- 03
The ISO 5 classified aseptic processing areas contained dust-collecting overhangs without…
This inspection in context
Brian J. Hettler
1 document · 2017
Cites 211.113 (control of microbiological contamination) 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 211.56
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 3 observations on this Form 483, mostly about facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected The Wellness Center Pharmacy, Inc., dba Designer Drugs?
Brian J. Hettler and Luis A. Tovar are named on this Form 483, for the inspection of Dec 12 – Dec 22, 2017. 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 Dec 12 – Dec 22, 2017, and the Form 483 is dated December 22, 2017.
How do I get the full Form 483 for The Wellness Center Pharmacy, Inc., dba Designer Drugs?
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.