Drug factory · FDA FEI 3003882011
Quotient Sciences - Philadelphia, LLC
3 Chelsea Pkwy Ste 305, Boothwyn, PA, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 17, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2010: 3 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Tovorafenib | Makes it | Day One Biopharmaceuticals, Inc. | 82950-001, 82950-012 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 17, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Dec 22, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Nov 6, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 2, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 7, 2013 | No problems found | Drug Quality Assurance | — |
| Jan 12, 2012 | No problems found | Drug Quality Assurance | — |
| Sep 9, 2010 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Sep 17, 2025 inspection
- Protective Apparel Not Worn 21 CFR 211.28(a)
Protective apparel is not worn as necessary to protect drug products from contamination. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Dec 22, 2022 inspection
- Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Registered with FDA for: analysis; manufacture.