Overview
- 9 public-safe observations are available for this inspection.
- 8 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.
14 Nov 2023
21 CFR 111.103
Written procedure quality control operations material review
Cited by Jonaida Estevez Martinez, Anthony L Smith
14 Nov 2023
21 CFR 111.153
Written procedures - product received; packaging, labeling
Cited by Jonaida Estevez Martinez, Anthony L Smith
14 Nov 2023
21 CFR 111.403
Written procedures - labeling operations
Cited by Jonaida Estevez Martinez, Anthony L Smith
14 Nov 2023
21 CFR 111.403
Written procedures -packaging operations
Cited by Jonaida Estevez Martinez, Anthony L Smith
14 Nov 2023
21 CFR 111.420(a)
Repackaging, relabeling - quality control, approve
Cited by Jonaida Estevez Martinez, Anthony L Smith
Inspected site
TITxsyn Int. LLCSan Antonio, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.403 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.153 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.420(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.465(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.475(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.503 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 observations
The full inspection record, as Atlas holds it, 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