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Tedor Pharma — Cumberland

Cumberland, Rhode Island, United States · CDMO

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

Site facts

Company
Tedor Pharma
Name(s) in FDA data
Tedor Pharma, Inc.
FEI number(s)
3003855180 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Cumberland, Rhode Island, United States 02864
Records matched
5 FDA inspections · 2 inspections with posted 483 citations
Most recent FDA inspection in dataset
05 Jun 2025 — VAI

Capabilities (from the company's website)

  • Small molecule
    …ality, cost-competitive development and manufacturing services for a growing portfolio of small molecule, solid dose products from development to commercialization. Based in Cumberland, RI (an h…
  • API / drug substance (chemical)
    …Learn More Formulation Development Produce stable, effective drug delivery platforms for active pharmaceutical ingredients (APIs) with our high-quality process development and validation services. Learn more Equ…
  • Clinical trial supply & packaging
    …y by simplifying tech transfer, offering secure shipping, and we manage raw materials and packaging components inventory to align with our partners’ requirements. In addition to providing i…
  • Analytical testing
    …A licensed to manufacture controlled substances schedules II through V. Likewise, our GMP analytical laboratory is licensed to handle substances schedules CI-CV. DEA License FDA Registered Wareh…
  • Formulation & process development
    …rements for characterization, testing, analytical development and quality assurance, from pre-formulation to commercialization. Learn More Clinical Trial Supply Services Leverage our expertise in…
  • Controlled substances
    …ems. Our facility is FDA registered and inspected, and we are DEA licensed to manufacture controlled substances schedules II through V. Likewise, our GMP analytical laboratory is licensed to handle su…

Taken from the company's web page for this site. Source: https://tedorpharma.com/about-us/our-facility/, 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. 05 Jun 2025
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 211.160(b): Scientifically sound laboratory controls
    • 21 CFR 211.25(a): Training--operations, GMPs, written procedures

    Source: FDA Data Dashboard – Citations (FEI 3003855180, inspection ID 1271887)

  2. 05 Jun 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 3003855180, inspection ID 1271887)

  3. 31 Jan 2019
    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 3003855180, inspection ID 1077786)

  4. 20 Apr 2017
    Form 483 observations 4 posted Form 483 citation(s)

    Citation summaries (4)
    • 21 CFR 211.113(a): Procedures for non-sterile drug products
    • 21 CFR 211.180(e)(2): Items to cover on annual reviews
    • 21 CFR 211.186(b)(9): Manufacturing Instructions and Specifications
    • 21 CFR 211.192: Extent of discrepancy, failure investigations

    Source: FDA Data Dashboard – Citations (FEI 3003855180, inspection ID 1010372)

  5. 20 Apr 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 3003855180, inspection ID 1010372)

  6. 29 Oct 2013
    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 3003855180, inspection ID 853221)

  7. 09 Sep 2011
    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 3003855180, inspection ID 743987)

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.