Nostrum Laboratories Inc – FDA Inspection, Nov 14, 2008

Record Details

This FDA Inspection record concerns Nostrum Laboratories Inc, with an inspection on November 14, 2008, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Nostrum Laboratories Inc
Inspection Date: November 14, 2008
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · 0a8fe6bb-c0c5-4dc2-89a6-a2f9f2c830ab

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 552659
FDA center: Human Drugs
Project area: Drug Quality Assurance

FDA Citations

21 CFR 211.110(a)Control procedures to monitor and validate performance
21 CFR 211.137(a)Expiration date lacking
21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
21 CFR 211.160(b)Scientifically sound laboratory controls
21 CFR 211.194(a)(5)Calculations performed are in the records
21 CFR 211.194(a)(8)Second person sign off
21 CFR 211.67(b)(3)Cleaning SOPs/instructions
21 CFR 211.165(a)Testing and release for distribution
21 CFR 211.165(e)Test methods
21 CFR 211.42(b)Product flow through building is inadequate

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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