FDA Inspection

Novadore USA, LLC.August 29, 2018

Novadore USA, LLC. – FDA Inspection, Aug 29, 2018

Record Details

This FDA Inspection record concerns Novadore USA, LLC., with an inspection on August 29, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Novadore USA, LLC.
Inspection Date: August 29, 2018
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Camerson E. Moore (FDA Associated Person)

View Company Profile

ID · ea389650-0bc0-4105-8004-3b6a35654511

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1063713
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.165(d)Acceptance criteria for sampling & testing
21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
21 CFR 211.110(a)Control procedures to monitor and validate performance
21 CFR 211.192Quality control unit review of records
21 CFR 211.198(a)Complaint Handling Procedure
21 CFR 211.204Returned drug procedures in writing and followed
21 CFR 211.142Written warehousing procedures established/followed
21 CFR 211.100(a)Absence of Written Procedures
21 CFR 211.22(a)Lack of quality control unit
21 CFR 211.166(a)Written program not followed

Showing 10 of 11 citations.

Full citation text and observation details available on the Dashboard.

Discuss this record with AI

KeyPedia

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Novadore USA, LLC.