Atlas

Form 483

Bayer de Mexico, S.A. de C.V. Form 483, 2015-10-23

FDA issued a Form 483 to Bayer de Mexico, S.A. de C.V. on 2015-10-23 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Bayer de Mexico, S.A. de C.V. · Lerma, Mexico · Issued October 23, 2015

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.

23 Oct 2015
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Alice S Tsao

23 Oct 2015
21 CFR 211.166(a)(3)

Valid stability test methods

Cited by Alice S Tsao

23 Oct 2015
21 CFR 211.170(b)

Annual visual exams of drug products

Cited by Alice S Tsao

Inspected site

BDBayer de Mexico, S.A. de C.V.Lerma, Mexico

Inspection team

ASAlice S Tsao

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.170(b)Cited 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