Atlas

Form 483

Lonza Tampa LLC Form 483, 2016-07-01

FDA issued a Form 483 to Lonza Tampa LLC on 2016-07-01 with 6 public-safe observations.

483· Form 483 issuedHuman Drugs6 observations

Lonza Tampa LLC · Tampa, United States · Issued July 1, 2016

Overview

  • 6 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

1 Jul 2016
21 CFR 211.160(a)

Lab controls established, including changes

Cited by Jennifer Lalama

1 Jul 2016
21 CFR 211.194(a)(2)

Laboratory Test Method Verification

Cited by Jennifer Lalama

1 Jul 2016
21 CFR 211.68(b)

Computer control of master formula records

Cited by Jennifer Lalama

1 Jul 2016
21 CFR 211.160(a)

Lab controls established, including changes

Cited by Jennifer Lalama

1 Jul 2016
21 CFR 211.194(a)(2)

Laboratory Test Method Verification

Cited by Jennifer Lalama

Inspected site

LTLonza Tampa LLCTampa, United States

Inspection team

JLJennifer Lalama

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(a)Cited across public-safe Form 483 observations2x
21 CFR 211.194(a)(2)Cited across public-safe Form 483 observations2x
21 CFR 211.68(b)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 6 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