Nostrum Laboratories Inc – FDA Inspection, Dec 1, 2009

Record Details

This FDA Inspection record concerns Nostrum Laboratories Inc, with an inspection on December 1, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Nostrum Laboratories Inc
Inspection Date: December 1, 2009
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · c84c8473-dd78-408b-a736-28f1b61076ec

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 631758
FDA center: Human Drugs
Project area: Drug Quality Assurance

FDA Citations

21 CFR 211.165(d)Acceptance criteria for sampling & testing
21 CFR 314.81(b)(2)(iv)(a)Reports re: chemical, physical, or other properties
21 CFR 211.137(a)Expiration date lacking
21 CFR 211.192Extent of discrepancy, failure investigations
21 CFR 211.160(b)Scientifically sound laboratory controls
21 CFR 211.165(e)Test methods
21 CFR 211.160(a)Lab controls established, including changes
21 CFR 211.192Investigations of discrepancies, failures
21 CFR 211.22(d)Procedures not in writing, fully followed
21 CFR 211.100(b)SOPs not followed / documented

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Other FDA inspections of Nostrum Laboratories Inc

Date	Classification	Office	Project area
April 2, 2026	Not classified	Kansas City District Office	Drug Quality Assurance
September 20, 2024	VAI	Kansas City District Office	Postmarketing Surveillance and Epidemiology: Human Drugs
September 13, 2024	Not classified	Kansas City District Office
April 21, 2021	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance
April 4, 2016	NAI	Center for Drug Evaluation and Research	Bioresearch Monitoring