Atlas

Form 483

Medipharm Laboratories, Inc Form 483, 2017-01-31

FDA issued a Form 483 to Medipharm Laboratories, Inc on 2017-01-31 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Medipharm Laboratories, Inc · Miami, United States · Issued January 31, 2017

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

31 Jan 2017
21 CFR 211.165(b)

Microbiological testing

Cited by Jennifer Lalama

31 Jan 2017
21 CFR 211.166(a)

Written program not followed

Cited by Jennifer Lalama

31 Jan 2017
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Jennifer Lalama

Inspected site

MLMedipharm Laboratories, IncMiami, United States

Inspection team

JLJennifer Lalama

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.165(b)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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