Baptist Health Medical Towers Pharmacy and Infusion Services
Form 483 issued May 13, 2016 · Little Rock, Arkansas
- Inspection
- Apr 13 – Apr 19, 2016
- Investigator
- Latorie S. Jones
- Observations
- 8
- Pages
- 6
- FEI number
- 3011624368
In short: On May 13, 2016, FDA issued a Form 483 with 8 observations to Baptist Health Medical Towers Pharmacy and Infusion Services in Little Rock, Arkansas (FEI 3011624368) after an inspection that ran Apr 13 – Apr 19, 2016. The investigator was Latorie S. Jones. 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 6 of 8 observations.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Latorie S. Jones
21 documents · 2015–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Arkansas.
The firmBaptist Health Medical Towers Pharmacy and Infusion Services history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Baptist Health Medical Towers Pharmacy and Infusion Services?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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 Baptist Health Medical Towers Pharmacy and Infusion Services?
Latorie S. Jones is named on this Form 483, for the inspection of Apr 13 – Apr 19, 2016. Each investigator has a profile showing what they cite most.
When was Baptist Health Medical Towers Pharmacy and Infusion Services inspected by FDA?
The inspection ran Apr 13 – Apr 19, 2016, and the Form 483 is dated May 13, 2016.
How do I get the full Form 483 for Baptist Health Medical Towers Pharmacy and Infusion Services?
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.