Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
1 Jul 2014
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Peter E Baker, Parul M Patel, Thomas J Arista
1 Jul 2014
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Peter E Baker, Parul M Patel, Thomas J Arista
1 Jul 2014
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Peter E Baker, Parul M Patel, Thomas J Arista
1 Jul 2014
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Peter E Baker, Parul M Patel, Thomas J Arista
Inspected site
ARApotex Research Private LimitedBengaluru, India
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 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | 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 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