Form 483

Somerset Therapeutics Private Limited Form 483, 2009-03-31

FDA issued a Form 483 to Somerset Therapeutics Private Limited on 2009-03-31 with 2 public-safe observations.

483· Form 483 issued2 observations

Somerset Therapeutics Private Limited · Bengaluru, India · Issued March 31, 2009

Overview

2 public-safe observations are available for this inspection.
2 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.

31 Mar 2009

21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Kenneth H Williams, Ramon A Hernandez

31 Mar 2009

21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Kenneth H Williams, Ramon A Hernandez

Inspected site

STSomerset Therapeutics Private LimitedBengaluru, India

Inspection team

KHKenneth H Williams

RARamon A Hernandez

Cited regulations

CFR citations associated with this Form 483.

Citation	What it covers	Cited
21 CFR 211.22(d)	Cited across public-safe Form 483 observations	1x
21 CFR 211.67(a)	Cited across public-safe Form 483 observations	1x

Full 483 report

Get the verbatim text of all 2 observations

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