Overview
- 19 public-safe observations are available for this inspection.
- 18 structured CFR citations are represented.
- 6 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
Adequate lab facilities not available
Cited by Julia E Chervoni, Sangeeta M Khurana, Anita Narula, Sharon I Gundersen, Lori J Silverstein, Heika R Tait
Procedures not in writing, fully followed
Cited by Julia E Chervoni, Sangeeta M Khurana, Anita Narula, Sharon I Gundersen, Lori J Silverstein, Heika R Tait
Cleaning / Sanitizing / Maintenance
Cited by Julia E Chervoni, Sangeeta M Khurana, Anita Narula, Sharon I Gundersen, Lori J Silverstein, Heika R Tait
SOPs not followed / documented
Cited by Julia E Chervoni, Sangeeta M Khurana, Anita Narula, Sharon I Gundersen, Lori J Silverstein, Heika R Tait
Procedures for non-sterile drug products
Cited by Julia E Chervoni, Sangeeta M Khurana, Anita Narula, Sharon I Gundersen, Lori J Silverstein, Heika R Tait
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 19 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