Form 483

EOS Products LLC Form 483, 2016-09-30

FDA issued a Form 483 to EOS Products LLC on 2016-09-30 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

EOS Products LLC · New York, United States · Issued September 30, 2016

Overview

  • 2 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

30 Sep 2016
21 CFR 211.198(a)

Complaint Handling Procedure

Cited by Andrew J Garufi, Goran Periz

30 Sep 2016
21 CFR 211.198(a)

Complaint Handling Procedure

Cited by Andrew J Garufi, Goran Periz

Inspected site

EPEOS Products LLCNew York, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.198(a)Cited across public-safe Form 483 observations2x

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