FDA Inspection
Quotient Sciences - Philadelphia, LLCQuotient Sciences - Philadelphia, LLC – FDA Inspection, Sep 17, 2025
Record Details
This FDA Inspection record concerns Quotient Sciences - Philadelphia, LLC, with an inspection on September 17, 2025, issued by the Philadelphia District Office, covering human drugs.
- Inspection Date
- September 17, 2025
- Product Type
- Human Drugs
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ID · 9ab4ad26-895e-4db7-b444-b5b782bc0591
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1282368
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Quotient Sciences - Philadelphia, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| December 22, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 6, 2017 | VAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| November 2, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 7, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 12, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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