Atlas

Form 483

BMC 1092, Inc. Form 483, 2016-09-28

FDA issued a Form 483 to BMC 1092, Inc. on 2016-09-28 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

BMC 1092, Inc. · Broadview, United States · Issued September 28, 2016

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.

28 Sep 2016
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Brian D Nicholson

28 Sep 2016
21 CFR 211.166(a)(3)

Valid stability test methods

Cited by Brian D Nicholson

28 Sep 2016
21 CFR 211.113(a)

Procedures for non-sterile drug products

Cited by Brian D Nicholson

Inspected site

B1BMC 1092, Inc.Broadview, United States

Inspection team

BDBrian D Nicholson

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 211.113(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(3)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