Nostrum Laboratories Inc – FDA Inspection, Nov 5, 2010

Record Details

This FDA Inspection record concerns Nostrum Laboratories Inc, with an inspection on November 5, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Nostrum Laboratories Inc
Inspection Date: November 5, 2010
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · cde26e34-178d-4e77-9cf5-0f5f83501f6f

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 697608
FDA center: Human Drugs
Project area: Drug Quality Assurance

FDA Citations

21 CFR 211.165(d)Acceptance criteria for sampling & testing
21 CFR 211.103Actual vs. theoretical yields not determined
21 CFR 211.166(b)Adequate number of batches on stability
21 CFR 211.110(a)Control procedures to monitor and validate performance
21 CFR 211.111Deviations of production time limits
21 CFR 211.25(a)Training , Education , Experience overall
21 CFR 211.192Extent of discrepancy, failure investigations
21 CFR 211.67(b)(3)Cleaning SOPs/instructions
21 CFR 211.115(a)Reprocessing procedures not written or followed
21 CFR 211.165(e)Test methods

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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