Atlas

Form 483

Cambridge Isotope Laboratories, Inc. Form 483, 2020-12-09

FDA issued a Form 483 to Cambridge Isotope Laboratories, Inc. on 2020-12-09 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Cambridge Isotope Laboratories, Inc. · Tewksbury, United States · Issued December 9, 2020

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

9 Dec 2020
21 CFR 212.20(d)

Determination need for investigation

Cited by Robert J Martin

9 Dec 2020
21 CFR 212.40(a)

Suitable for intended use

Cited by Robert J Martin

9 Dec 2020
21 CFR 212.40(b)

Written specifications - containers and closures

Cited by Robert J Martin

9 Dec 2020
21 CFR 212.50

Adequate controls (general)

Cited by Robert J Martin

Inspected site

CICambridge Isotope Laboratories, Inc.Tewksbury, United States

Inspection team

RJRobert J Martin

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 212.20(d)Cited across public-safe Form 483 observations1x
21 CFR 212.40(a)Cited across public-safe Form 483 observations1x
21 CFR 212.40(b)Cited across public-safe Form 483 observations1x
21 CFR 212.50Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Book a demoStart a free trial

Full 483 report

Get the verbatim text of all 4 observations

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