SBH Medical LTD
Form 483 issued September 30, 2019 · Worthington, Ohio
- Inspection
- Sep 9 – Sep 30, 2019
- Investigators
- Andrew J. Barrowcliff· Ucheabuchi C. Chudi-Nwankwor
- Observations
- 1
- Pages
- 1
- FEI number
- 3015242029
In short: On September 30, 2019, FDA issued a Form 483 with 1 observation to SBH Medical LTD in Worthington, Ohio (FEI 3015242029) after an inspection that ran Sep 9 – Sep 30, 2019. The investigators were Andrew J. Barrowcliff and Ucheabuchi C. Chudi-Nwankwor. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities…
This inspection in context
Andrew J. Barrowcliff
5 documents · 2018–2023
Cites 211.22(d) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Ohio.
The firmSBH Medical LTD history
The site's inspection history, in date order.
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 SBH Medical LTD?
FDA listed 1 observation on this Form 483, mostly about production. 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 SBH Medical LTD?
Andrew J. Barrowcliff and Ucheabuchi C. Chudi-Nwankwor are named on this Form 483, for the inspection of Sep 9 – Sep 30, 2019. Each investigator has a profile showing what they cite most.
When was SBH Medical LTD inspected by FDA?
The inspection ran Sep 9 – Sep 30, 2019, and the Form 483 is dated September 30, 2019.
How do I get the full Form 483 for SBH Medical LTD?
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.