Form 483

Indiana Botanic Gardens, Inc Form 483, 2015-03-27

FDA issued a Form 483 to Indiana Botanic Gardens, Inc on 2015-03-27 with 9 public-safe observations.

483· Form 483 issuedHuman Drugs9 observations

Indiana Botanic Gardens, Inc · Hobart, United States · Issued March 27, 2015

Overview

  • 9 public-safe observations are available for this inspection.
  • 9 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.

27 Mar 2015
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Sarah M Meng

27 Mar 2015
21 CFR 211.125(f)

Procedures Written and Followed

Cited by Sarah M Meng

27 Mar 2015
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Sarah M Meng

27 Mar 2015
21 CFR 211.166(a)

Lack of written stability program

Cited by Sarah M Meng

27 Mar 2015
21 CFR 211.180(e)(1)

Review of representative number of batches

Cited by Sarah M Meng

Inspected site

IBIndiana Botanic Gardens, IncHobart, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.125(f)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 9 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