Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
14 Sep 2016
21 CFR 111.95(a)
Records - production, process control: electronic
Cited by Massoud Motamed
14 Sep 2016
21 CFR 211.198(b)(2)
Written record of complaint to include findings, follow-up
Cited by Massoud Motamed
Inspected site
MLMylan Laboratories LimitedNasik, Nashik, India
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.95(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(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 6 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