Form 483

Green Pharmaceuticals Inc Form 483, 2010-09-15

FDA issued a Form 483 to Green Pharmaceuticals Inc on 2010-09-15 with 10 public-safe observations.

483· Form 483 issued10 observations

Green Pharmaceuticals Inc · Camarillo, United States · Issued September 15, 2010

Overview

  • 10 public-safe observations are available for this inspection.
  • 10 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.

15 Sep 2010
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Maxyne T Lam

15 Sep 2010
21 CFR 211.125(f)

Procedures Written and Followed

Cited by Maxyne T Lam

15 Sep 2010
21 CFR 211.134(c)

Examinations documented

Cited by Maxyne T Lam

15 Sep 2010
21 CFR 211.142(a)

Quarantine - actual practice

Cited by Maxyne T Lam

15 Sep 2010
21 CFR 211.170(b)(1)

Retention time of reserve samples, in general

Cited by Maxyne T Lam

Inspected site

GPGreen Pharmaceuticals IncCamarillo, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.125(f)Cited across public-safe Form 483 observations1x
21 CFR 211.134(c)Cited across public-safe Form 483 observations1x
21 CFR 211.142(a)Cited across public-safe Form 483 observations1x
21 CFR 211.170(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)Cited across public-safe Form 483 observations1x
21 CFR 211.184(d)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(8)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.198(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 10 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