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Form 483

Lonza Tampa LLC Form 483, 2018-07-20

FDA issued a Form 483 to Lonza Tampa LLC on 2018-07-20 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Lonza Tampa LLC · Tampa, United States · Issued July 20, 2018

Overview

  • 2 public-safe observations are 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.

20 Jul 2018
21 CFR 211.160(a)

Deviations from laboratory control requirements

Cited by Scott T Ballard

20 Jul 2018
21 CFR 211.160(a)

Deviations from laboratory control requirements

Cited by Scott T Ballard

Inspected site

LTLonza Tampa LLCTampa, United States

Inspection team

STScott T Ballard

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(a)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF and 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