Overview
- 5 public-safe observations are available for this inspection.
- 5 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 Jun 2015
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Meisha R Sampson, Satheesh Thomas, Meisha R Waters
22 Jun 2015
21 CFR 211.110(a)
Written in-process control procedures
Cited by Meisha R Sampson, Satheesh Thomas, Meisha R Waters
22 Jun 2015
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Meisha R Sampson, Satheesh Thomas, Meisha R Waters
22 Jun 2015
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Meisha R Sampson, Satheesh Thomas, Meisha R Waters
22 Jun 2015
21 CFR 211.80(a)
Procedures To Be in Writing
Cited by Meisha R Sampson, Satheesh Thomas, Meisha R Waters
Inspected site
TPTeva Pharmaceutical IndustriesJerusalem, Israel
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 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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