Atlas

Form 483

Grisi Hnos, S.A. de C.V. Form 483, 2022-10-21

FDA issued a Form 483 to Grisi Hnos, S.A. de C.V. on 2022-10-21 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Grisi Hnos, S.A. de C.V. · Ciudad De Mexico, Mexico · Issued October 21, 2022

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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 Oct 2022
21 CFR 211.198(b)

Maintenance of Complaint File

Cited by Christopher M Jenner, Tiara M Brown

21 Oct 2022
21 CFR 211.80(a)

Written Procedures Not Followed

Cited by Christopher M Jenner, Tiara M Brown

21 Oct 2022
21 CFR 211.84(b)

Representative Samples

Cited by Christopher M Jenner, Tiara M Brown

Inspected site

GHGrisi Hnos, S.A. de C.V.Ciudad De Mexico, Mexico

Inspection team

CMChristopher M Jenner
TMTiara M Brown

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.198(b)Cited across public-safe Form 483 observations1x
21 CFR 211.80(a)Cited across public-safe Form 483 observations1x
21 CFR 211.84(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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