Overview
- 10 public-safe observations are available for this inspection.
- 10 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.
23 Feb 2012
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Jose A Cruz Gonzalez, Ivis L Negron Torres, Xiaokuang Lai
23 Feb 2012
21 CFR 211.56(b)
Written sanitation procedures not followed
Cited by Jose A Cruz Gonzalez, Ivis L Negron Torres, Xiaokuang Lai
23 Feb 2012
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Jose A Cruz Gonzalez, Ivis L Negron Torres, Xiaokuang Lai
23 Feb 2012
21 CFR 211.110(a)
Written in-process control procedures
Cited by Jose A Cruz Gonzalez, Ivis L Negron Torres, Xiaokuang Lai
23 Feb 2012
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Jose A Cruz Gonzalez, Ivis L Negron Torres, Xiaokuang Lai
Inspected site
ZLZydus Lifesciences LimitedAhmedabad, India
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 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | 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