Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
8 Nov 2010
21 CFR 211.22(a)
Authority lacking to review records, investigate errors
Cited by Christopher T Middendorf, Tracey L Harris, Anna M Brannen
8 Nov 2010
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Christopher T Middendorf, Tracey L Harris, Anna M Brannen
8 Nov 2010
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Christopher T Middendorf, Tracey L Harris, Anna M Brannen
8 Nov 2010
21 CFR 211.28(a)
Protective Apparel Not Worn
Cited by Christopher T Middendorf, Tracey L Harris, Anna M Brannen
8 Nov 2010
21 CFR 211.110(a)
Written in-process control procedures
Cited by Christopher T Middendorf, Tracey L Harris, Anna M Brannen
Inspected site
TWTeva Womens Health, LLCCincinnati, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | 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 7 observations
The source PDF and 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