Baptist Health Medical Towers Pharmacy and Infusion Services
Form 483 issued March 12, 2019 · Little Rock, Arkansas
- Inspection
- Mar 5 – Mar 6, 2020
- Investigator
- Jennifer L. Huntington
- Observations
- 3
- Pages
- 2
- FEI number
- 3011624368
In short: On March 12, 2019, FDA issued a Form 483 with 3 observations to Baptist Health Medical Towers Pharmacy and Infusion Services in Little Rock, Arkansas (FEI 3011624368) after an inspection that ran Mar 5 – Mar 6, 2020. The investigator was Jennifer L. Huntington. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 3 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×) · 211.42 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Materials or supplies were not disinfected prior to entering…
- 02
Your facility design allowed the influx of poor quality air into…
- 03
Media fills were not performed that closely s imulate aseptic production operations incorporating, as appropriate, worst-case…
This inspection in context
Jennifer L. Huntington
31 documents · 2015–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
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 211.113
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 3 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Baptist Health Medical Towers Pharmacy and Infusion Services?
Jennifer L. Huntington is named on this Form 483, for the inspection of Mar 5 – Mar 6, 2020. 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 Mar 5 – Mar 6, 2020, and the Form 483 is dated March 12, 2019.
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.