Lonza Tampa LLC
Form 483 issued July 20, 2018 · Tampa, Florida
- Inspection
- Jul 16 – Jul 20, 2018
- Investigator
- Scott Ballard
- Observations
- 1
- Pages
- 2
- FEI number
- 3001549109
In short: On July 20, 2018, FDA issued a Form 483 with 1 observation to Lonza Tampa LLC in Tampa, Florida (FEI 3001549109) after an inspection that ran Jul 16 – Jul 20, 2018. The investigator was Scott Ballard. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Deviations from written test procedures are…
This inspection in context
Scott Ballard
30 documents · 2011–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lonza Tampa LLC?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Lonza Tampa LLC?
Scott Ballard is named on this Form 483, for the inspection of Jul 16 – Jul 20, 2018. Each investigator has a profile showing what they cite most.
When was Lonza Tampa LLC inspected by FDA?
The inspection ran Jul 16 – Jul 20, 2018, and the Form 483 is dated July 20, 2018.
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.