FDA Inspection
SCS Direct Inc.SCS Direct Inc. – FDA Inspection, Aug 23, 2016
Record Details
This FDA Inspection record concerns SCS Direct Inc., with an inspection on August 23, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- SCS Direct Inc.
- Inspection Date
- August 23, 2016
- Product Type
- Drugs
View Company Profile
ID · bb245a06-aa50-4cb7-a7c0-4e8994705770
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 982567
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
5- 21 CFR 211.150(b)Recall facilitation
- 21 CFR 211.196Distribution Record Requirements
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.22(a)Lack of quality control unit
Full citation text and observation details available on the Dashboard.
Other FDA inspections of SCS Direct Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 12, 2017 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
Other documents for SCS Direct Inc.
- FDA Inspection 1013191 - 2017-05-12
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.