FDA Inspection 1064322 - Osteotec Limited - September 04, 2018

FDA Inspection 1064322 for Osteotec Limited on September 04, 2018. Classification: Official Action Indicated (OAI).

One-time purchase from the GKS catalog. Lifetime access in your library. Single documents and full company profiles available. All sales final.

Record Summary

FDA Inspection 1064322 for Osteotec Limited on September 04, 2018. Classification: Official Action Indicated (OAI).

Violation Codes

21 CFR 803.17

21 CFR 820.198(a)

21 CFR 820.22

21 CFR 820.30(c)

21 CFR 820.30(f)

21 CFR 820.30(g)

21 CFR 820.50

Get More Insights

Access our comprehensive regulatory intelligence platform to analyze patterns, track compliance trends, and stay ahead of regulatory changes.

1.5M+ regulatory data points

Real-time compliance monitoring

Interactive analytics dashboard

Looking for more records? Our platform provides access to thousands of similar regulatory documents with advanced search and filtering capabilities.

Record Information

Company

Osteotec Limited

Inspection Date

September 4, 2018

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: ff62d752-b80f-440d-af10-4b399b17c146

View on Dashboard

Transform Regulatory Data into Actionable Intelligence

Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.

Try KeyPedia Today

Explore our real use cases and discover our features in depth.

Subscribe to our newsletter

Get the latest updates and insights delivered to your inbox