Atlas

Form 483

Sight Society Of Northeastern New York/Lions Eye Bank of the Northeast Form 483, 2010-02-22

FDA issued a Form 483 to Sight Society Of Northeastern New York/Lions Eye Bank of the Northeast on 2010-02-22 with 3 public-safe observations.

483· Form 483 issued3 observations

Sight Society Of Northeastern New York/Lions Eye Bank of the Northeast · Albany, United States · Issued February 22, 2010

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 Feb 2010
21 CFR 1271.265(b)

Shipment in quarantine of HCT/Ps

Cited by Michael G Sinkevich

22 Feb 2010
21 CFR 1271.265(c)(1)

Release criteria verified, documented

Cited by Michael G Sinkevich

22 Feb 2010
21 CFR 1271.270(e)

Contract firms--identities and responsibilities

Cited by Michael G Sinkevich

Inspected site

SSSight Society Of Northeastern New York/Lions Eye Bank of the NortheastAlbany, United States

Inspection team

MGMichael G Sinkevich

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.265(b)Cited across public-safe Form 483 observations1x
21 CFR 1271.265(c)(1)Cited across public-safe Form 483 observations1x
21 CFR 1271.270(e)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