Atlas

Form 483

Cryos International USA, LLC Form 483, 2015-07-15

FDA issued a Form 483 to Cryos International USA, LLC on 2015-07-15 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

Cryos International USA, LLC · Orlando, United States · Issued July 15, 2015

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.

15 Jul 2015
21 CFR 1271.50(a)

Responsible person to determine, document

Cited by Stacey F Rivette

15 Jul 2015
21 CFR 1271.75(e)

Abbreviated procedure

Cited by Stacey F Rivette

15 Jul 2015
21 CFR 1271.80(b)

Specimen collections not timely

Cited by Stacey F Rivette

Inspected site

CICryos International USA, LLCOrlando, United States

Inspection team

SFStacey F Rivette

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.50(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.75(e)Cited across public-safe Form 483 observations1x
21 CFR 1271.80(b)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