Stanley Specialty Pharmacy Compounding and Wellness Center
Form 483 issued July 7, 2016 · Charlotte, North Carolina
- Inspection
- Jun 7 – Jul 7, 2016
- Investigator
- Bonita S. Chester
- Observations
- 4
- Pages
- 2
- FEI number
- 3012184662
In short: On July 7, 2016, FDA issued a Form 483 with 4 observations to Stanley Specialty Pharmacy Compounding and Wellness Center in Charlotte, North Carolina (FEI 3012184662) after an inspection that ran Jun 7 – Jul 7, 2016. The investigator was Bonita S. Chester. 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 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Protective apparel is not worn as necessary to protect…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the…
This inspection in context
Bonita S. Chester
17 documents · 2013–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in North Carolina.
The firmStanley Specialty Pharmacy Compounding and Wellness Center history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Stanley Specialty Pharmacy Compounding and Wellness Center?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment 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 Stanley Specialty Pharmacy Compounding and Wellness Center?
Bonita S. Chester is named on this Form 483, for the inspection of Jun 7 – Jul 7, 2016. Each investigator has a profile showing what they cite most.
When was Stanley Specialty Pharmacy Compounding and Wellness Center inspected by FDA?
The inspection ran Jun 7 – Jul 7, 2016, and the Form 483 is dated July 7, 2016.
How do I get the full Form 483 for Stanley Specialty Pharmacy Compounding 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.