Atlas

Form 483

Kindeva Drug Delivery L.P. Form 483, 2010-02-12

FDA issued a Form 483 to Kindeva Drug Delivery L.P. on 2010-02-12 with 2 public-safe observations.

483· Form 483 issued2 observations

Kindeva Drug Delivery L.P. · Northridge, United States · Issued February 12, 2010

Overview

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

12 Feb 2010
21 CFR 211.67(b)

Written procedures fail to include

Cited by Uttaniti Limchumroon, Kelvin X Sanders, Maxyne T Lam

12 Feb 2010
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Uttaniti Limchumroon, Kelvin X Sanders, Maxyne T Lam

Inspected site

KDKindeva Drug Delivery L.P.Northridge, United States

Inspection team

ULUttaniti Limchumroon
KXKelvin X Sanders
MTMaxyne T Lam

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x

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