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Quotient Sciences — Boothwyn

Boothwyn, Pennsylvania, United States · CDMO

This is a record of what regulators published, not a rating.

Site facts

Company
Quotient Sciences
Name(s) in FDA data
Quotient Sciences - Philadelphia, LLC
FEI number(s)
3003882011 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Boothwyn, Pennsylvania, United States 19061
Records matched
7 FDA inspections · 2 inspections with posted 483 citations
Most recent FDA inspection in dataset
17 Sep 2025 — VAI

Capabilities (from the company's website)

  • Small molecule
    …Senior Director, Quality Operations Nichole Caparelli has over 20 years of experience in small molecule manufacturing from development through commercialization with ... About Nichole Amit Pate…
  • API / drug substance (chemical)
    …ormulation Development Clinical Trial Manufacturing Commercial Manufacturing High Potency APIs (HPAPIs) Handling & Manufacturing All Services Read News About Quotient Sciences - Boothw…
  • Highly potent (HPAPI)
    …es we offer Formulation Development Clinical Trial Manufacturing Commercial Manufacturing High Potency APIs (HPAPIs) Handling & Manufacturing All Services Read News About Quotient Sciences - B…
  • Microbiology
    …acturing suites Solid oral dosage forms HPAPI handling - recently expanded Analytical and microbiology laboratories Tech transfer & scale-up Process optimization & validation Commercial manuf…
  • Formulation & process development
    …rkway Boothwyn, PA 19061 USA Tel. (610) 485-4270 Call Us Get Directions Services we offer Formulation Development Clinical Trial Manufacturing Commercial Manufacturing High Potency APIs (HPAPIs) Handling…

Taken from the company's web page for this site. Source: https://quotientsciences.com/about/locations/boothwyn-philadelphia-pa-usa, checked 16 Oct 2026. Quoted text shows the wording each tag is based on.

Regulatory timeline

Newest first. Each entry links to the published source. Inspection classifications: NAI = no action indicated, VAI = voluntary action indicated, OAI = official action indicated (FDA definitions). Posted 483 citations are FDA's short summaries, not the full Form 483.

  1. 17 Sep 2025
    Form 483 observations 3 posted Form 483 citation(s)

    Citation summaries (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

    Source: FDA Data Dashboard – Citations (FEI 3003882011, inspection ID 1282368)

  2. 17 Sep 2025
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3003882011, inspection ID 1282368)

  3. 22 Dec 2022
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.67(a): Cleaning / Sanitizing / Maintenance

    Source: FDA Data Dashboard – Citations (FEI 3003882011, inspection ID 1195157)

  4. 22 Dec 2022
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3003882011, inspection ID 1195157)

  5. 06 Nov 2017
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3003882011, inspection ID 1030748)

  6. 02 Nov 2015
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3003882011, inspection ID 947209)

  7. 07 Nov 2013
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3003882011, inspection ID 854922)

  8. 12 Jan 2012
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3003882011, inspection ID 763294)

  9. 09 Sep 2010
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3003882011, inspection ID 681158)

This is a record of what regulators published, not a rating. Absence of a record here does not mean no record exists; see methodology for what we check and how records are matched.