Atlas

Form 483

Zermat Internacional, S.A. de C.V. Form 483, 2014-09-12

FDA issued a Form 483 to Zermat Internacional, S.A. de C.V. on 2014-09-12 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Zermat Internacional, S.A. de C.V. · Tlalnepantla, Mexico · Issued September 12, 2014

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

12 Sep 2014
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Heriberto Negron-Rivera

12 Sep 2014
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Heriberto Negron-Rivera

12 Sep 2014
21 CFR 211.137(a)

Expiration date lacking

Cited by Heriberto Negron-Rivera

12 Sep 2014
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Heriberto Negron-Rivera

Inspected site

ZIZermat Internacional, S.A. de C.V.Tlalnepantla, Mexico

Inspection team

HNHeriberto Negron-Rivera

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.137(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(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 4 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