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Quotient Sciences - Philadelphia, LLC

FDA establishment 3003882011, Boothwyn, Pennsylvania, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.

  • Inspections: 7
  • Official action indicated: 0
  • Last inspection ended: Sep 17, 2025
  • Warning letters: 0

Inspections by Fiscal Year

FY2018 to FY2027 to date; 0 classified OAI

Most Cited at This Site

Inspections citing each reference

Inspections

7 inspections, newest first
EndedProduct and areaCitationsClassification
Sep 17, 2025Drugs · Drug Quality Assurance
3 cited references
  • 21 CFR 211.67(b). Written procedures not established/followed 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.
  • 21 CFR 211.28(a). Protective Apparel Not Worn Protective apparel is not worn as necessary to protect drug products from contamination.
  • 21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance 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.
Voluntary Action Indicated (VAI)
Dec 22, 2022Drugs · Drug Quality Assurance
1 cited reference
  • 21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance 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.
Voluntary Action Indicated (VAI)
Nov 6, 2017Drugs · Drug Quality AssuranceNone postedVoluntary Action Indicated (VAI)
Nov 2, 2015Drugs · Drug Quality AssuranceNone postedVoluntary Action Indicated (VAI)
Nov 7, 2013Drugs · Drug Quality AssuranceNone postedNo Action Indicated (NAI)
Jan 12, 2012Drugs · Drug Quality AssuranceNone postedNo Action Indicated (NAI)
Sep 9, 2010Drugs · Drug Quality AssuranceNone postedNo Action Indicated (NAI)

Identifiers

FEI number
3003882011
FDA firm profile
Data Dashboard

An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard and warning letters

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.