Ultrum Labs LLC
FDA inspection history in Tampa, Florida, 2023
- 1
- Form 483
Every document, by year
- Form 483
2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One Form 483, at Tampa, Florida.
Cited most
Across all Ultrum Labs observations on file
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.67(b)Equipment cleaning and maintenance1
- 21 CFR 211.68(b)Automatic, mechanical, and electronic equipment1
- 21 CFR 211.84(a)Testing and approval or rejection of components, drug product containers, and closures1
The complete Ultrum Labs file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Tampa, Florida
One Form 483 · 2023 · 6 observations
Latest: Form 483, Oct 16, 2023 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-10-16 | 483 Form 483 | Tampa, Florida | 6 | $99 |
Investigators on these documents
FEI number 3017953600 · most recent document Oct 16, 2023
About Ultrum Labs LLC
How many FDA Form 483s has Ultrum Labs LLC received?
FDA Intel has 1 Form 483 on file for Ultrum Labs LLC; the most recent is dated Oct 16, 2023.
When was Ultrum Labs LLC last inspected by FDA?
The most recent FDA inspection document on file for Ultrum Labs LLC is a Form 483 dated Oct 16, 2023, for the site in Tampa, Florida.
What did FDA cite at Ultrum Labs LLC?
The regulations cited most in the observations on file for Ultrum Labs LLC are 21 CFR 211.100(a) (Written procedures; deviations), 2 times; 21 CFR 211.22(d) (Responsibilities of quality control unit), 1 time; 21 CFR 211.67(b) (Equipment cleaning and maintenance), 1 time.