Atlas

Form 483

The Hospital of Central Connecticut at New Britain General/BB Form 483, 2018-01-24

FDA issued a Form 483 to The Hospital of Central Connecticut at New Britain General/BB on 2018-01-24 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

The Hospital of Central Connecticut at New Britain General/BB · New Britain, United States · Issued January 24, 2018

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

24 Jan 2018
21 CFR 211.68(b)

input/output verification

Cited by Anthony N Onianwa

24 Jan 2018
21 CFR 606.121(c)(2)

Name, address, unique facility identifier

Cited by Anthony N Onianwa

Inspected site

THThe Hospital of Central Connecticut at New Britain General/BBNew Britain, United States

Inspection team

ANAnthony N Onianwa

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x
21 CFR 606.121(c)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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