FDA Inspection
SSG VenturesSSG Ventures – FDA Inspection, Jan 2, 2019
Record Details
This FDA Inspection record concerns SSG Ventures, with an inspection on January 2, 2019, issued by the New York District Office, covering human drugs.
- Office
- New York District Office
- Person
- Jay T. Wong (Issuing Officer)
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ID · 3f598100-8bdd-4196-87cd-90b4189c3192
Inspection Facts
- Inspection number
- 1075787
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(b)Written procedures fail to include
Showing 10 of 12 citations.
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Other FDA inspections of SSG Ventures
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 30, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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