Overview
- 9 public-safe observations are available for this inspection.
- 9 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
22 Aug 2025
21 CFR 211.110(c)
In-process materials characteristics testing
Cited by Nicole E Knowlton, Santos E Camara, Kayla V Sprague
22 Aug 2025
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Nicole E Knowlton, Santos E Camara, Kayla V Sprague
22 Aug 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Nicole E Knowlton, Santos E Camara, Kayla V Sprague
22 Aug 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Nicole E Knowlton, Santos E Camara, Kayla V Sprague
22 Aug 2025
21 CFR 211.46(b)
Equipment for Environmental Control
Cited by Nicole E Knowlton, Santos E Camara, Kayla V Sprague
Inspected site
LTLonza Tampa LLCTampa, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 9 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere