Dongkook Pharmaceutical Co., Ltd. – FDA Inspection, Nov 30, 2018

Record Details

This FDA Inspection record concerns Dongkook Pharmaceutical Co., Ltd., with an inspection on November 30, 2018, issued by the Office of Inspections and Investigations, covering human drugs.

Company: Dongkook Pharmaceutical Co., Ltd.
Inspection Date: November 30, 2018
Product Type: Human Drugs
Office: Office of Inspections and Investigations
Person: Nicole E. Knowlton (FDA Associated Person)

View Company Profile

ID · b54d827e-95b0-4422-94bc-af13226e56a6

Inspection Facts

Inspection number: 1074954
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.166(a)Lack of written stability program
21 CFR 211.22(c)Approve or reject procedures or specs
21 CFR 211.84(d)(2)Establish reliability of supplier's C of A

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 Dongkook Pharmaceutical Co., Ltd.

FDA Inspection

Dongkook Pharmaceutical Co., Ltd.November 30, 2018