Overview
- 4 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
8 Jan 2015
21 CFR 211.103
Yield calculations not verified by 2nd person
Cited by Shafiq Ahadi, Edward E Lockwood
8 Jan 2015
21 CFR 211.192
Quality control unit review of records
Cited by Shafiq Ahadi, Edward E Lockwood
8 Jan 2015
21 CFR 314.81(b)(2)(iv)(b)
Mfg and control changes not requiring a supplemental app.
Cited by Shafiq Ahadi, Edward E Lockwood
Inspected site
CUCurium US LLCMaryland Heights, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(2)(iv)(b) | 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 4 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