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Form 483

Keystone Laboratories, Inc. Form 483, 2015-03-13

FDA issued a Form 483 to Keystone Laboratories, Inc. on 2015-03-13 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Keystone Laboratories, Inc. · Memphis, United States · Issued March 13, 2015

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.

13 Mar 2015
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Laura L Staples

13 Mar 2015
21 CFR 211.165(a)

Testing and release for distribution

Cited by Laura L Staples

13 Mar 2015
21 CFR 211.166(a)(3)

Valid stability test methods

Cited by Laura L Staples

13 Mar 2015
21 CFR 211.58

Buildings not maintained in good state of repair

Cited by Laura L Staples

Inspected site

KLKeystone Laboratories, Inc.Memphis, United States

Inspection team

LLLaura L Staples

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited across public-safe Form 483 observations1x

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 4 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