Form 483

Continental Services Group, Inc. Form 483, 2017-08-22

FDA issued a Form 483 to Continental Services Group, Inc. on 2017-08-22 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

Continental Services Group, Inc. · Miami, United States · Issued August 22, 2017

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.

22 Aug 2017
21 CFR 606.170(a)

Adverse Reaction- Reports of Investigations

Cited by Laura E Garcia

22 Aug 2017
21 CFR 606.40(a)(1)

Provide space for examination

Cited by Laura E Garcia

22 Aug 2017
21 CFR 640.65(b)(1)(iii)

Greater than six months since four month sample

Cited by Laura E Garcia

Inspected site

CSContinental Services Group, Inc.Miami, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.170(a)Cited across public-safe Form 483 observations1x
21 CFR 606.40(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 640.65(b)(1)(iii)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