Atlas

Form 483

Medical Chemical Corporation Form 483, 2010-08-31

FDA issued a Form 483 to Medical Chemical Corporation on 2010-08-31 with 12 public-safe observations.

483· Form 483 issued12 observations

Medical Chemical Corporation · Torrance, United States · Issued August 31, 2010

Overview

  • 12 public-safe observations are available for this inspection.
  • 11 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 Aug 2010
21 CFR 211.68(a)

Calibration/Inspection/Checking not done

Cited by Comyar Shoghi, Juanita Banuelos

31 Aug 2010
21 CFR 211.100(a)

Changes to Procedures Not Reviewed, Approved

Cited by Comyar Shoghi, Juanita Banuelos

31 Aug 2010
21 CFR 211.130(e)

Packaging line inspection documentation

Cited by Comyar Shoghi, Juanita Banuelos

31 Aug 2010
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Comyar Shoghi, Juanita Banuelos

31 Aug 2010
21 CFR 211.160(b)(4)

Calibration - at intervals, written program, remedial action

Cited by Comyar Shoghi, Juanita Banuelos

Inspected site

MCMedical Chemical CorporationTorrance, United States

Inspection team

CSComyar Shoghi
JBJuanita Banuelos

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.22Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.130(e)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 820.25(b)Cited across public-safe Form 483 observations1x
21 CFR 820.50(b)Cited across public-safe Form 483 observations1x
21 CFR 820.70(a)Cited across public-safe Form 483 observations1x
21 CFR 820.80(e)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 12 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