Form 483

Public Health England Form 483, 2013-03-08

FDA issued a Form 483 to Public Health England on 2013-03-08 with 10 public-safe observations.

483· Form 483 issuedHuman Drugs10 observations

Public Health England · Salisbury, United Kingdom · Issued March 8, 2013

Overview

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

Inspectional observations

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

8 Mar 2013
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Julianne C Mccullough, Barbara D Paul

8 Mar 2013
21 CFR 211.42(a)

Buildings of Suitable Size, Construction, Location

Cited by Julianne C Mccullough, Barbara D Paul

8 Mar 2013
21 CFR 211.56(b)

Written sanitation procedures lacking

Cited by Julianne C Mccullough, Barbara D Paul

8 Mar 2013
21 CFR 211.84(b)

Representative Samples

Cited by Julianne C Mccullough, Barbara D Paul

8 Mar 2013
21 CFR 211.84(d)(3)

Testing Containers & Closures Conformity with Specs

Cited by Julianne C Mccullough, Barbara D Paul

Inspected site

PHPublic Health EnglandSalisbury, United Kingdom

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.110(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(6)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.42(a)Cited across public-safe Form 483 observations1x
21 CFR 211.56(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.94(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 10 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