FDA Inspection
JD & SN Inc.JD & SN Inc. – FDA Inspection, Jul 21, 2015
Record Details
This FDA Inspection record concerns JD & SN Inc., with an inspection on July 21, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- JD & SN Inc.
- Inspection Date
- July 21, 2015
- Product Type
- Drugs
View Company Profile
ID · beddff05-860a-4b69-a906-4ca830a496fa
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 935807
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
20- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.101(d)Verification of component addition
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
Showing 10 of 20 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of JD & SN Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 4, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 12, 2017 | Not classified | Seattle District Office |
Other documents for JD & SN Inc.
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.