FDA Inspection
Kashiv BioSciences, LLCKashiv BioSciences, LLC – FDA Inspection, Sep 4, 2026
Record Details
This FDA Inspection record concerns Kashiv BioSciences, LLC, with an inspection on September 4, 2026, issued by the Chicago District Office, covering human drugs.
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ID · ddfb8f24-936d-45ac-a689-c8569eebb787
Inspection Facts
- Inspection number
- 1298244
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.84(d)(1)Component identity verification
- ISO 13485:2016 Clause 7.1Processes needed for product realization not planned and developed
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
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Other FDA inspections of Kashiv BioSciences, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 14, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 12, 2019 | Not classified | Chicago District Office | |
| January 26, 2018 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 21, 2017 | Not classified | Chicago District Office | |
| February 9, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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