Shenzhen Oriental Pharmaceutical Co LtdJanuary 7, 2019

FDA 483 - Shenzhen Oriental Pharmaceutical Co Ltd - January 07, 2019

View on Dashboard

Discuss this record with AI

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 Shenzhen Oriental Pharmaceutical Co Ltd

Record Details

Shenzhen Oriental Pharmaceutical Co., Ltd., an API manufacturer in Longgang District, Shenzhen, China, was cited with four observations during an FDA inspection. The inspection revealed significant issues with out-of-specification investigations, lack of Quality Assurance preapproval for testing protocols, unexplained deviations in annual product reviews, and concerns regarding valve and piping connections in cleanroom production areas. These findings indicate deficiencies in quality control and manufacturing processes.

Company: Shenzhen Oriental Pharmaceutical Co Ltd
Inspection Date: January 7, 2019
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Matthew B. Casale ( Investigator )

Open in Dashboard

ID · 17c7343e-7e99-44ef-8c81-517170bd7508