Overview
- 4 public-safe observations are available for this inspection.
- 2 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
25 Aug 2023
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Margaret M Annes, Rodney L Tinzie
25 Aug 2023
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Margaret M Annes, Rodney L Tinzie
25 Aug 2023
21 CFR 211.84(d)(2)
Establish reliability of supplier's C of A
Cited by Margaret M Annes, Rodney L Tinzie
25 Aug 2023
21 CFR 211.84(d)(2)
Establish reliability of supplier's C of A
Cited by Margaret M Annes, Rodney L Tinzie
Inspected site
NTNeos Therapeutics, LPGrand Prairie, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 2x |
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 4 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