Nonclinical Laboratories Inspected
Under FDA GLP Regulations
(Title 21, Code of Federal Regulations, Part 58)
SINCE FISCAL YEAR 1990

Contents

• Active Tox Labs List

• University Labs List

• Foreign Labs List

• Inactive Labs List

• Glossary:
  Contact Persons
  Inspection Codes
  Codes Not in Use
  Miscellaneous Abbrevs.

Introduction - Contents - Glossary

About the List:

Nonclinical laboratory studies are experiments in which test articles (food additives, color additives, drug or biological products, electronic products, medical devices for human use) are studied in test systems (animals, plants, microorganisms, or subparts thereof) under laboratory conditions to determine their safety.

The Food and Drug Administration (FDA) regulates the conduct of nonclinical laboratory studies under Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies) of Title 21 of the Code of Federal Regulations. FDA inspects facilities that conduct nonclinical laboratory studies to determine the facilities compliance with part 58.

The following is a list of the testing facilities that have been inspected since October 1, 1989. The list provides the current name and former (if known) names of the testing facility, the dates the facility has been inspected, and the classification of the inspection results (see description below). The list is updated quarterly.

The inspection dates may not be in chronological order because the inspection assignments are issued on a quarterly basis and reports may not have been entered in chronological order.

• Ruark Lanham
  MSODL Investigator / Program Expert
  Bioresearch Monitoring
  Division of Field Investigations, HFC0-130
  Office of Regulatory Affairs
  US Food and Drug Administration
  5600 Fishers Lane
  Rockville, MD 20857
  Phone: (301) 827 - 6691
  Electronic mail: Ruark.Lanham@fda.hhs.gov

Glossary

• CAN: Canceled

  NAI: No Action Indicated. No objectionable conditions or practices were found during the inspection (or the objectionable conditions found do not justify further regulatory action).

  NCC: Non Classified

  NIM: No Inspection Made.

  OAI: Official Action Indicated. Regulatory and administrative actions will be recommended.

  PEN: Pending review and classification.

  RTC: Refer to Center:  Establishment Inspection Report had been forwarded to Center for final review and classification.

  VAI: Voluntary Action Indicated. Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

  WO: Washout: Firm was visited or inspected, however, not performing regulated studies at time of inspection.

• VAI-1: Establishment has made voluntary corrections in such a manner that the objectionable conditions are not likely to recur and routine reinspection is indicated.

  VAI-2: Establishment advised by investigator or other district communication of objectionable conditions that should be corrected; however, the significance is such that routine reinspection is indicated.

  VAI-3: Objectionable conditions do not justify official action at this time but the evidence shows that the conditions, if not corrected, could reasonably result in or lead to conditions that would support official action.

• dba: Doing Business As.

  fka: Formerly Known As - Former name(s) of the establishment.

  OOB: Establishment is Out of Business as a nonclinical laboratory.

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