Cumberland Biotherapeutics LLC
Form 483 issued June 27, 2024 · Sewanee, Tennessee
- Inspection
- Jun 25 – Jun 27, 2024
- Investigator
- Benjamin E. Bowen
- Observations
- 2
- Pages
- 5
- FEI number
- 3025666291
In short: On June 27, 2024, FDA issued a Form 483 with 2 observations to Cumberland Biotherapeutics LLC in Sewanee, Tennessee (FEI 3025666291) after an inspection that ran Jun 25 – Jun 27, 2024. The investigator was Benjamin E. Bowen. Most observations concern management controls and production & process controls; the most-cited regulation is 21 CFR 820.20 (management responsibility).
At a glance
Management controls and production & process controls account for 2 of 2 observations.
Most cited: 21 CFR 820.20(a) (1×) · 820.50 (1×)
What FDA observed
Preview: the opening words of each observation- 01
The quality objectives was/were not established by…
- 02
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
This inspection in context
Benjamin E. Bowen
4 documents · 2021–2025
Cites 820.50 (purchasing controls) more than any other section. Most of their documents are for sites in Tennessee.
The firmCumberland Biotherapeutics LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.20(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cumberland Biotherapeutics LLC?
FDA listed 2 observations on this Form 483, mostly about management controls and production & process controls. The most-cited regulation is 21 CFR 820.20 (management responsibility). The opening words of each observation are shown on this page.
Who inspected Cumberland Biotherapeutics LLC?
Benjamin E. Bowen is named on this Form 483, for the inspection of Jun 25 – Jun 27, 2024. Each investigator has a profile showing what they cite most.
When was Cumberland Biotherapeutics LLC inspected by FDA?
The inspection ran Jun 25 – Jun 27, 2024, and the Form 483 is dated June 27, 2024.
How do I get the full Form 483 for Cumberland Biotherapeutics LLC?
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.