Lonza Tampa LLC
Form 483 issued October 1, 2021 · TAMPA, Florida
- Inspection
- Sep 27 – Oct 1, 2021
- Investigators
- Kayla V. Sprague· Lillian M. Colon-Mcknight
- Observations
- 2
- Pages
- 4
- FEI number
- 3001549109
In short: On October 1, 2021, FDA issued a Form 483 with 2 observations to Lonza Tampa LLC in TAMPA, Florida (FEI 3001549109) after an inspection that ran Sep 27 – Oct 1, 2021. The investigators were Kayla V. Sprague and Lillian M. Colon-Mcknight. Most observations concern quality system and production.
At a glance
Quality system and production account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks authority to review production records to assure that no errors have…
- 02
The master production and control records are deficient in that they do not include complete manufacturing…
This inspection in context
Kayla V. Sprague
17 documents · 2020–2026
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Florida.
The firmLonza Tampa LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lonza Tampa LLC?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The opening words of each observation are shown on this page.
Who inspected Lonza Tampa LLC?
Kayla V. Sprague and Lillian M. Colon-Mcknight are named on this Form 483, for the inspection of Sep 27 – Oct 1, 2021. Each investigator has a profile showing what they cite most.
When was Lonza Tampa LLC inspected by FDA?
The inspection ran Sep 27 – Oct 1, 2021, and the Form 483 is dated October 1, 2021.
How do I get the full Form 483 for Lonza Tampa 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.