Form 483

Rosemont Pharmaceuticals Ltd. Form 483, 2014-12-12

FDA issued a Form 483 to Rosemont Pharmaceuticals Ltd. on 2014-12-12 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Rosemont Pharmaceuticals Ltd. · Leeds, United Kingdom · Issued December 12, 2014

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

12 Dec 2014
21 CFR 211.166(a)

Results not used for expiration dates, storage cond.

Cited by Luis A Dasta

Inspected site

RPRosemont Pharmaceuticals Ltd.Leeds, United Kingdom

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x

Full 483 report

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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