Lonza Tampa LLC
FDA inspection history across 2 sites, 2018 to 2023
- 3
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2021: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Tampa, Florida.
- 2021–23Two Form 483s, at TAMPA, Florida.
- 2021The longest 483 on file: 2 observations over 4 pages at TAMPA, Florida.
Cited most
Across all Lonza Tampa observations on file
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.160General requirements1
- 21 CFR 211.186Master production and control records1
- 21 CFR 211.192Production record review1
The complete Lonza Tampa file.
All 3 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
TAMPA, Florida
Two Form 483s · 2021 to 2023 · 3 observations
Latest: Form 483, Sep 29, 2023 →Tampa, Florida
One Form 483 · 2018 · 1 observation
Latest: Form 483, Jul 20, 2018 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-09-29 | 483 Form 483 | TAMPA, Florida | 1 | $99 |
| 2021-10-01 | 483 Form 483 | TAMPA, Florida | 2 | $99 |
| 2018-07-20 | 483 Form 483 | Tampa, Florida | 1 | $99 |
Investigators on these documents
Kayla V. Sprague (1)Lillian M. Colon-Mcknight (1)Scott Ballard (1)
FEI number 3001549109 · most recent document Sep 29, 2023
About Lonza Tampa LLC
How many FDA Form 483s has Lonza Tampa LLC received?
FDA Intel has 3 Form 483s on file for Lonza Tampa LLC; the most recent is dated Sep 29, 2023.
When was Lonza Tampa LLC last inspected by FDA?
The most recent FDA inspection document on file for Lonza Tampa LLC is a Form 483 dated Sep 29, 2023, for the site in TAMPA, Florida.
What did FDA cite at Lonza Tampa LLC?
The regulations cited most in the observations on file for Lonza Tampa LLC are 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.186 (Master production and control records), 1 time.