Tsukioka Film Pharma Co., Ltd. – FDA Inspection, May 24, 2019

Record Details

This FDA Inspection record concerns Tsukioka Film Pharma Co., Ltd., with an inspection on May 24, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Tsukioka Film Pharma Co., Ltd.
Inspection Date: May 24, 2019
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Saundrea A. Munroe (FDA Associated Person)

View Company Profile

ID · 45bb14a4-b8d3-44b5-a24d-5b8671d98284

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1090547
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
21 CFR 211.165(e)Test methods
21 CFR 211.192Investigations of discrepancies, failures

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 Tsukioka Film Pharma Co., Ltd.

FDA Inspection

Tsukioka Film Pharma Co., Ltd.May 24, 2019