John L. McClellan Memorial Veterans Hospital
Form 483 issued January 23, 2020 · Little Rock, Arkansas
- Inspection
- Jan 13 – Jan 23, 2020
- Investigators
- June P. Page· Mina Ahmadi
- Observations
- 8
- Pages
- 6
- FEI number
- 3013521045
In short: On January 23, 2020, FDA issued a Form 483 with 8 observations to John L. McClellan Memorial Veterans Hospital in Little Rock, Arkansas (FEI 3013521045) after an inspection that ran Jan 13 – Jan 23, 2020. The investigators were June P. Page and Mina Ahmadi. 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 7 of 8 observations.
Most cited: 21 CFR 211.42 (3×) · 211.28 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing…
- 02
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was…
- 03
Equipment was not disinfected prior to entering…
- 04
Your facility design allowed the influx of poor-quality air into…
This inspection in context
June P. Page
30 documents · 2015–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in India.
The firmJohn L. McClellan Memorial Veterans Hospital history
The site's inspection history, in date order.
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 John L. McClellan Memorial Veterans Hospital?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, production and quality system. 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 John L. McClellan Memorial Veterans Hospital?
June P. Page and Mina Ahmadi are named on this Form 483, for the inspection of Jan 13 – Jan 23, 2020. Each investigator has a profile showing what they cite most.
When was John L. McClellan Memorial Veterans Hospital inspected by FDA?
The inspection ran Jan 13 – Jan 23, 2020, and the Form 483 is dated January 23, 2020.
How do I get the full Form 483 for John L. McClellan Memorial Veterans Hospital?
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.