Form 483

ART Reproductive Center, LLC Form 483, 2018-03-23

FDA issued a Form 483 to ART Reproductive Center, LLC on 2018-03-23 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

ART Reproductive Center, LLC · Beverly Hills, United States · Issued March 23, 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.

23 Mar 2018
21 CFR 1271.65(b)(2)

Labeled re: biohazard, risks, test results

Cited by Peter S Kessler

23 Mar 2018
21 CFR 1271.90(b)

Eligibility not required--warning labels

Cited by Peter S Kessler

23 Mar 2018
21 CFR 1271.90(c)

Eligibility not required--warning labels

Cited by Peter S Kessler

Inspected site

ARART Reproductive Center, LLCBeverly Hills, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.65(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 1271.90(b)Cited across public-safe Form 483 observations1x
21 CFR 1271.90(c)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