Overview
- 25 public-safe observations are available for this inspection.
- 8 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.
5 Feb 2019
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Michele Perry-Williams, Bei Y He
5 Feb 2019
21 CFR 211.194(a)
Complete test data included in records
Cited by Michele Perry-Williams, Bei Y He
5 Feb 2019
21 CFR 211.22(a)
Approve or reject components, products
Cited by Michele Perry-Williams, Bei Y He
Inspected site
SAS and B Pharma, Inc dba Alkem LaboratoriesFenton, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(b)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 3x |
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 25 observations
The source PDF and 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