Form 483

V Manufacturing & Logistics, Inc. Form 483, 2015-01-28

FDA issued a Form 483 to V Manufacturing & Logistics, Inc. on 2015-01-28 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

V Manufacturing & Logistics, Inc. · Walnut, United States · Issued January 28, 2015

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.

28 Jan 2015
21 CFR 211.194(a)(1)

Sample identification and other information

Cited by Sangeeta M Khurana

28 Jan 2015
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Sangeeta M Khurana

28 Jan 2015
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Sangeeta M Khurana

28 Jan 2015
21 CFR 211.68(a)

Calibration/Inspection/Checking not done

Cited by Sangeeta M Khurana

Inspected site

VMV Manufacturing & Logistics, Inc.Walnut, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.194(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.68(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