Form 483

MPP PHARMA LLC Form 483, 2021-04-21

FDA issued a Form 483 to MPP PHARMA LLC on 2021-04-21 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

MPP PHARMA LLC · Kansas City, United States · Issued April 21, 2021

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

21 Apr 2021
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Carl A Huffman, Torrey M Ward

21 Apr 2021
21 CFR 211.192

Extent of discrepancy, failure investigations

Cited by Carl A Huffman, Torrey M Ward

Inspected site

MPMPP PHARMA LLCKansas City, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 2 observations

The source PDF, 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