OMEZA LLC
FDA inspection history in Sarasota, Florida, 2023
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2023: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One warning letter and one Form 483, at Sarasota, Florida.
Cited most
Across all OMEZA observations on file
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.186(b)(9)Master production and control records1
- 21 CFR 211.56(a)Sanitation1
- 21 CFR 211.67(b)Equipment cleaning and maintenance1
The complete OMEZA file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Sarasota, Florida
One warning letter and one Form 483 · 2023 · 6 observations
Latest: Warning letter, Dec 12, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-12-12 | Warning letter Warning letter | Sarasota, Florida | — | $99 |
| 2023-07-28 | 483 Form 483 | Sarasota, Florida | 6 | $99 |
Investigators on these documents
FEI number 3019843904 · most recent document Dec 12, 2023
About OMEZA LLC
How many FDA Form 483s has OMEZA LLC received?
FDA Intel has 1 Form 483 on file for OMEZA LLC; the most recent is dated Jul 28, 2023.
When was OMEZA LLC last inspected by FDA?
The most recent FDA inspection document on file for OMEZA LLC is a Form 483 dated Jul 28, 2023, for the site in Sarasota, Florida.
What did FDA cite at OMEZA LLC?
The regulations cited most in the observations on file for OMEZA LLC are 21 CFR 211.165(a) (Testing and release for distribution), 1 time; 21 CFR 211.166(a) (Stability testing), 1 time; 21 CFR 211.186(b)(9) (Master production and control records), 1 time.
Has OMEZA LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for OMEZA LLC; the most recent is dated Dec 12, 2023.