FDA Inspection
Hysan Pharmaceutical Co., Ltd.Hysan Pharmaceutical Co., Ltd. – FDA Inspection, Mar 29, 2018
Record Details
This FDA Inspection record concerns Hysan Pharmaceutical Co., Ltd., with an inspection on March 29, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 4c571815-cdb2-4a4c-8a8c-a289b1de074e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1047429
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.194(e)Stability testing records not included
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.122(a)Written procedures describing in detail
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.182Written records kept in individual logs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Hysan Pharmaceutical Co., Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 12, 2025 | VAI | Office of Inspections and Investigations | Drug Quality Assurance |
| September 10, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 11, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Hysan Pharmaceutical Co., Ltd.
- FDA Inspection 1274837 - 2025-06-12
- FDA Inspection 941851 - 2015-09-10
- FDA Inspection 822258 - 2012-10-11
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.