Overview
- 1 public-safe observation is available for this inspection.
- 1 structured CFR citation is represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
14 Feb 2019
21 CFR 211.63
Equipment Design, Size and Location
Cited by Bijoy Panicker, Nicholas A Violand
Inspected site
OSONESOURCE SPECIALTY PHARMA LIMITEDBengaluru, India
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
Source document
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Form 483 source document
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Full 483 report
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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