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Form 483

Lonza Tampa LLC Form 483, 2023-09-29

FDA issued a Form 483 to Lonza Tampa LLC on 2023-09-29 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Lonza Tampa LLC · Tampa, United States · Issued September 29, 2023

Overview

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

Inspectional observations

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

29 Sep 2023
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Kayla V Sprague, Suzanne N Vallez, Megan T Ziegler

Inspected site

LTLonza Tampa LLCTampa, United States

Inspection team

KVKayla V Sprague
SNSuzanne N Vallez
MTMegan T Ziegler

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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Full 483 report

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The source PDF, 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