Ultrum Labs LLC
Form 483 issued October 16, 2023 · Tampa, Florida
- Inspection
- Oct 10 – Oct 16, 2023
- Investigators
- Damaris Y. Hernandez· Nicole E. Knowlton
- Observations
- 6
- Pages
- 7
- FEI number
- 3017953600
In short: On October 16, 2023, FDA issued a Form 483 with 6 observations to Ultrum Labs LLC in Tampa, Florida (FEI 3017953600) after an inspection that ran Oct 10 – Oct 16, 2023. The investigators were Damaris Y. Hernandez and Nicole E. Knowlton. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Facilities & equipment and production account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Each lot of is not withheld from use until the lot has been sampled, tested, examined…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Written production and process control procedures are not followed in the execution of production and process…
This inspection in context
Damaris Y. Hernandez
17 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Florida.
The firmUltrum Labs LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ultrum Labs LLC?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and materials. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Ultrum Labs LLC?
Damaris Y. Hernandez and Nicole E. Knowlton are named on this Form 483, for the inspection of Oct 10 – Oct 16, 2023. Each investigator has a profile showing what they cite most.
When was Ultrum Labs LLC inspected by FDA?
The inspection ran Oct 10 – Oct 16, 2023, and the Form 483 is dated October 16, 2023.
How do I get the full Form 483 for Ultrum Labs 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.