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Form 483

Bayer de Mexico, S.A. de C.V. Form 483, 2022-12-09

FDA issued a Form 483 to Bayer de Mexico, S.A. de C.V. on 2022-12-09 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Bayer de Mexico, S.A. de C.V. · Lerma, Mexico · Issued December 9, 2022

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.

9 Dec 2022
21 CFR 211.170(b)

Annual visual exams of drug products

Cited by Maria Estrella, Alan L Truong

9 Dec 2022
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Maria Estrella, Alan L Truong

Inspected site

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

Inspection team

MEMaria Estrella
ALAlan L Truong

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.170(b)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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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