Overview
- 3 public-safe observations are available for this inspection.
- 3 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.
13 Sep 2013
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Santos E Camara, Blondell W Johnson
13 Sep 2013
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Santos E Camara, Blondell W Johnson
13 Sep 2013
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Santos E Camara, Blondell W Johnson
Inspected site
SPStrides Pharma Science LimitedChengalpattu, India
Inspection team
BWBlondell W Johnson
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | 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 3 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