Atlas

Form 483

Reese Pharmaceutical Company Form 483, 2009-08-04

FDA issued a Form 483 to Reese Pharmaceutical Company on 2009-08-04 with 3 public-safe observations.

483· Form 483 issued3 observations

Reese Pharmaceutical Company · Cleveland, United States · Issued August 4, 2009

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.

4 Aug 2009
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Janet L Bowen

4 Aug 2009
21 CFR 211.125(a)

Strict control not exercised over labeling issued

Cited by Janet L Bowen

4 Aug 2009
21 CFR 211.170(b)

Reserve samples identified, representative, stored

Cited by Janet L Bowen

Inspected site

RPReese Pharmaceutical CompanyCleveland, United States

Inspection team

JLJanet L Bowen

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.125(a)Cited across public-safe Form 483 observations1x
21 CFR 211.170(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