Atlas

Form 483

Selder, S.A. de C.V. Form 483, 2018-06-01

FDA issued a Form 483 to Selder, S.A. de C.V. on 2018-06-01 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Selder, S.A. de C.V. · Ciudad De Mexico, Mexico · Issued June 1, 2018

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.

1 Jun 2018
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Nicholas L Hunt

1 Jun 2018
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Nicholas L Hunt

1 Jun 2018
21 CFR 211.165(f)

Failing drug products not rejected

Cited by Nicholas L Hunt

Inspected site

SSSelder, S.A. de C.V.Ciudad De Mexico, Mexico

Inspection team

NLNicholas L Hunt

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(f)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 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