Atlas

Form 483

AstraZeneca AB Form 483, 2018-10-11

FDA issued a Form 483 to AstraZeneca AB on 2018-10-11 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

AstraZeneca AB · Sodertalje, Sweden · Issued October 11, 2018

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

11 Oct 2018
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by James A Lane, Truong X Nguyen, Yong Hu

Inspected site

AAAstraZeneca ABSodertalje, Sweden

Inspection team

JAJames A Lane
TXTruong X Nguyen
YHYong Hu

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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