Form 483

MedisourceRx Form 483, 2020-10-22

FDA issued a Form 483 to MedisourceRx on 2020-10-22 with 7 public-safe observations.

483· Form 483 issuedHuman Drugs7 observations

MedisourceRx · Los Alamitos, United States · Issued October 22, 2020

Overview

  • 7 public-safe observations are available for this inspection.
  • 6 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.

22 Oct 2020
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Liming Zhang

22 Oct 2020
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Liming Zhang

22 Oct 2020
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Liming Zhang

22 Oct 2020
21 CFR 211.186(b)(9)

Manufacturing Instructions and Specifications

Cited by Liming Zhang

22 Oct 2020
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Liming Zhang

Inspected site

MMedisourceRxLos Alamitos, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations2x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.186(b)(9)Cited 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 211.84(d)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 7 observations

The full inspection record, as Atlas holds it, 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