Atlas

Form 483

Lonza Tampa LLC Form 483, 2017-01-13

FDA issued a Form 483 to Lonza Tampa LLC on 2017-01-13 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Lonza Tampa LLC · Tampa, United States · Issued January 13, 2017

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

13 Jan 2017
21 CFR 211.166(a)

Written program not followed

Cited by Jessica L Pressley, Jennifer Lalama

13 Jan 2017
21 CFR 211.170(b)

Annual visual exams of drug products

Cited by Jessica L Pressley, Jennifer Lalama

13 Jan 2017
21 CFR 211.192

Written record of investigation incomplete

Cited by Jessica L Pressley, Jennifer Lalama

Inspected site

LTLonza Tampa LLCTampa, United States

Inspection team

JLJessica L Pressley
JLJennifer Lalama

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.170(b)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

The full inspection record, as Atlas holds it, 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