Overton Brooks VA Medical Center
Form 483 issued February 12, 2020 · Shreveport, Louisiana
- Inspection
- Feb 3 – Feb 12, 2020
- Investigators
- Brandon C. Heitmeier· June P. Page
- Observations
- 3
- Pages
- 3
- FEI number
- 3013236711
In short: On February 12, 2020, FDA issued a Form 483 with 3 observations to Overton Brooks VA Medical Center in Shreveport, Louisiana (FEI 3013236711) after an inspection that ran Feb 3 – Feb 12, 2020. The investigators were Brandon C. Heitmeier and June P. Page. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 1 system, led by facilities & equipment.
Most cited: 21 CFR 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
The ISO 5 classified aseptic processing area was located within a non-classified…
- 02
Equipment in close enough proximity to the ISO 5 area that could compromise the air in…
- 03
The facility design of your segregated production area does not have a suitable construction to facilitate…
This inspection in context
Brandon C. Heitmeier
12 documents · 2009–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Tennessee.
The firmOverton Brooks VA Medical Center history
All 3 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 Overton Brooks VA Medical Center?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment. 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 Overton Brooks VA Medical Center?
Brandon C. Heitmeier and June P. Page are named on this Form 483, for the inspection of Feb 3 – Feb 12, 2020. Each investigator has a profile showing what they cite most.
When was Overton Brooks VA Medical Center inspected by FDA?
The inspection ran Feb 3 – Feb 12, 2020, and the Form 483 is dated February 12, 2020.
How do I get the full Form 483 for Overton Brooks VA Medical 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.