Atlas

Form 483

Farmaqro, S.A. de C.V. Form 483, 2018-05-25

FDA issued a Form 483 to Farmaqro, S.A. de C.V. on 2018-05-25 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Farmaqro, S.A. de C.V. · Santiago De Queretaro, Mexico · Issued May 25, 2018

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

25 May 2018
21 CFR 211.110(b)

In-process conformity - examination, sample testing

Cited by Nicholas L Hunt

25 May 2018
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Nicholas L Hunt

Inspected site

FSFarmaqro, S.A. de C.V.Santiago De Queretaro, Mexico

Inspection team

NLNicholas L Hunt

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.110(b)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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