Overton Brooks VA Medical Center
Form 483 issued February 17, 2017 · Shreveport, Louisiana
- Inspection
- Feb 6 – Feb 17, 2017
- Investigators
- June P. Page· Oluwaseun N. Dedeke
- Observations
- 10
- Pages
- 6
- FEI number
- 3013236711
In short: On February 17, 2017, FDA issued a Form 483 with 10 observations to Overton Brooks VA Medical Center in Shreveport, Louisiana (FEI 3013236711) after an inspection that ran Feb 6 – Feb 17, 2017. The investigators were June P. Page and Oluwaseun N. Dedeke. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
6 of 10 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (6×) · 211.56 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The system for cleaning and disinfecting the aseptic…
- 02
Your firm continued producing sterile drug products while construction was ongoing within your facility without establishing…
- 03
The system for monitoring and maintaining environmental conditions in the aseptic…
- 04
Personnel were observed touching equipment or other surfaces located outside of the ISO 5 area with…
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 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 211.113
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 10 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 Overton Brooks VA Medical Center?
June P. Page and Oluwaseun N. Dedeke are named on this Form 483, for the inspection of Feb 6 – Feb 17, 2017. Each investigator has a profile showing what they cite most.
When was Overton Brooks VA Medical Center inspected by FDA?
The inspection ran Feb 6 – Feb 17, 2017, and the Form 483 is dated February 17, 2017.
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.