Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
Control procedures to monitor and validate performance
Cited by Jie He, Rafeeq A Habeeb, Sudipan Karmakar, Jacob G Lutz, Kara J Wright, Scott D Mcgrew
Procedures for sterile drug products
Cited by Jie He, Rafeeq A Habeeb, Sudipan Karmakar, Jacob G Lutz, Kara J Wright, Scott D Mcgrew
Procedures not in writing, fully followed
Cited by Jie He, Rafeeq A Habeeb, Sudipan Karmakar, Jacob G Lutz, Kara J Wright, Scott D Mcgrew
Written procedures not established/followed
Cited by Jie He, Rafeeq A Habeeb, Sudipan Karmakar, Jacob G Lutz, Kara J Wright, Scott D Mcgrew
Establish reliability of supplier's C of A
Cited by Jie He, Rafeeq A Habeeb, Sudipan Karmakar, Jacob G Lutz, Kara J Wright, Scott D Mcgrew
Inspected site
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(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(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Source document
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 5 observations
The source PDF, 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