Overview
- 10 public-safe observations are available for this inspection.
- 10 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
6 May 2011
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Nicholas A Violand, Juanita P Versace, Addam S Reynolds, Erin D Mccaffery
6 May 2011
21 CFR 211.28(c)
Unauthorized Personnel in Limited Access Areas
Cited by Nicholas A Violand, Juanita P Versace, Addam S Reynolds, Erin D Mccaffery
6 May 2011
21 CFR 211.63
Equipment Design, Size and Location
Cited by Nicholas A Violand, Juanita P Versace, Addam S Reynolds, Erin D Mccaffery
6 May 2011
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Nicholas A Violand, Juanita P Versace, Addam S Reynolds, Erin D Mccaffery
6 May 2011
21 CFR 211.68(b)
Computer control of master formula records
Cited by Nicholas A Violand, Juanita P Versace, Addam S Reynolds, Erin D Mccaffery
Inspected site
TPTris Pharma Inc.Monmouth Junction, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 10 observations
Every observation in full, 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