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Thermo Fisher Scientific (Patheon) — Manati

Manati, Puerto Rico, United States · CDMO

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

Site facts

Company
Thermo Fisher Scientific (Patheon)
Name(s) in FDA data
Patheon Puerto Rico, Inc.
FEI number(s)
3003113148 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Manati, Puerto Rico, United States 00674
Records matched
9 FDA inspections · 4 inspections with posted 483 citations
Most recent FDA inspection in dataset
12 Jul 2022 — VAI

Capabilities (from the company's website)

  • Highly potent (HPAPI)
    …s facilitate explosion-proof manufacturing, including solvent coating of tablets and high-potent compounds. This flexible facility also has a low-humidity manufacturing suite for moisture-sensiti…
  • Oral solid dose
    …Manatí, Puerto Rico, US Contact us Download fact sheet Oral solid dose Our Manatí facility specializes in the medium to high volume commercial manufacture…
  • Controlled substances
    …and an analytical registration (Schedule II, II-N, III, III-N to V, Listed Chemicals) for controlled substances in the U.S. High potent compounds using dry blend and granulation processes (tablets and…

Taken from the company's web page for this site. Source: https://www.patheon.com/us/en/site-locations/manati-pr.html, 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. 12 Jul 2022
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 211.100(b): SOPs not followed / documented
    • 21 CFR 211.58: Buildings not maintained in good state of repair

    Source: FDA Data Dashboard – Citations (FEI 3003113148, inspection ID 1174359)

  2. 12 Jul 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 3003113148, inspection ID 1174359)

  3. 15 Oct 2019
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 211.100(b): SOPs not followed / documented
    • 21 CFR 211.192: Investigations of discrepancies, failures

    Source: FDA Data Dashboard – Citations (FEI 3003113148, inspection ID 1106702)

  4. 15 Oct 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 3003113148, inspection ID 1106702)

  5. 31 May 2018
    Form 483 observations 3 posted Form 483 citation(s)

    Citation summaries (3)
    • 21 CFR 211.130(b): Unlabeled filled containers controls
    • 21 CFR 211.160(b): Scientifically sound laboratory controls
    • 21 CFR 211.192: Investigations of discrepancies, failures

    Source: FDA Data Dashboard – Citations (FEI 3003113148, inspection ID 1053901)

  6. 31 May 2018
    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 3003113148, inspection ID 1053901)

  7. 21 Jun 2016
    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 3003113148, inspection ID 976890)

  8. 03 Sep 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 3003113148, inspection ID 941475)

  9. 11 Aug 2014
    Form 483 observations 6 posted Form 483 citation(s)

    Citation summaries (6)
    • 21 CFR 211.100(a): Absence of Written Procedures
    • 21 CFR 211.160(b): Scientifically sound laboratory controls
    • 21 CFR 211.165(a): Testing and release for distribution
    • 21 CFR 211.165(d): Acceptance criteria for sampling & testing
    • 21 CFR 211.67(b): Written procedures not established/followed
    • 21 CFR 211.68(a): Calibration/Inspection/Checking not done

    Source: FDA Data Dashboard – Citations (FEI 3003113148, inspection ID 891131)

  10. 11 Aug 2014
    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 3003113148, inspection ID 891131)

  11. 12 Jun 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 3003113148, inspection ID 840440)

  12. 15 Jun 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 3003113148, inspection ID 729681)

  13. 04 Feb 2009
    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 3003113148, inspection ID 561874)

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.