Form 483

Modesto Junior College Form 483, 2012-08-02

FDA issued a Form 483 to Modesto Junior College on 2012-08-02 with 4 public-safe observations.

483· Form 483 issued4 observations

Modesto Junior College · Modesto, United States · Issued August 2, 2012

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

2 Aug 2012
21 CFR 530.11(a)

Species or class

Cited by Karla J Gibler, Jessica B Darneille, Annie H Lam

2 Aug 2012
21 CFR 530.11(d)

Tissue residue

Cited by Karla J Gibler, Jessica B Darneille, Annie H Lam

2 Aug 2012
FDCA 402(a)(4)

Record keeping

Cited by Karla J Gibler, Jessica B Darneille, Annie H Lam

2 Aug 2012
FDCA 501(a)(5)

Expired drugs

Cited by Karla J Gibler, Jessica B Darneille, Annie H Lam

Inspected site

MJModesto Junior CollegeModesto, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 530.11(a)Cited across public-safe Form 483 observations1x
21 CFR 530.11(d)Cited across public-safe Form 483 observations1x
FDCA 402(a)(4)Cited across public-safe Form 483 observations1x
FDCA 501(a)(5)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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