Directory › Pharmaceutics International (Pii)

Pharmaceutics International (Pii) — Hunt Valley

Hunt Valley, Maryland, United States · CDMO

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

Site facts

Company
Pharmaceutics International (Pii)
Name(s) in FDA data
Pharmaceutics International Inc
FEI number(s)
1000513101 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Hunt Valley, Maryland, United States 21031
Records matched
14 FDA inspections · 1 inspection with posted 483 citations
Most recent FDA inspection in dataset
06 Dec 2024 — VAI

Capabilities (from the company's website)

  • Sterile fill-finish
    …lex and unique projects. Perfect your formula Aseptic Drug Manufacturing Count on sterile fill-finish with the injectables CDMO that handles your toughest drug products without missing a beat…
  • Lyophilization
    …tion (CDMO) specializing in early stage, clinical, and commercial volume aseptic filling, lyophilization, and oral solid dose manufacturing, completed February 3, 2025. November 19, 2024 Pi…
  • Highly potent (HPAPI)
    …y. Let’s get your project moving CDMO Services That Don’t Quit We don’t do ordinary. From potent compounds to complex formulations, we take on the projects others run from—and we get it done, no…
  • Oral solid dose
    …g Manufacturing Keep your drug moving toward commercial success with custom solutions for tablets, soft gels, and liquids. Oral dose done right About Pii, A Jabil Company We specialize in…
  • Softgels
    …no excuses. Whether it’s aseptic injectables, complex oral dosage forms, or high-potency soft gels, you’ll receive custom, phase-appropriate support throughout your project’s lifecycle to…
  • Clinical trial supply & packaging
    …on of its prefilled syringe (PFS) capabilities with a $3.6 million investment in advanced labeling, fill/finish, and automated visual inspection technologies. See what’s new Code Snippet m…
  • Analytical testing
    …ct’s lifecycle to ensure your drug product moves smoothly on its path to market. Contract Analytical Services Get fast, reliable data with our analytical CDMO services, ensuring quality and complianc…
  • Formulation & process development
    …uring quality and compliance for headache-free drug development. Reliable testing support Formulation Development Services Boost bioavailability, stability, and adherence early on when you choose a drug…

Taken from a company-level page; the company does not publish a separate page for this site, so tags may describe the wider organisation. Source: https://www.pharm-int.com/, 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. 06 Dec 2024
    Form 483 observations 4 posted Form 483 citation(s)

    Citation summaries (4)
    • 21 CFR 211.160(b)(4): Establishment of calibration procedures
    • 21 CFR 211.63: Equipment Design, Size and Location
    • 21 CFR 211.67(b)(3): Cleaning SOPs/instructions
    • 21 CFR 211.84(d)(2): Reports of Analysis (Components)

    Source: FDA Data Dashboard – Citations (FEI 1000513101, inspection ID 1251950)

  2. 06 Dec 2024
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Monitoring of Marketed Animal Drugs, Feed, and Devices.

    Source: FDA Data Dashboard – Inspections (FEI 1000513101, inspection ID 1251950)

  3. 14 Nov 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 1000513101, inspection ID 1194130)

  4. 29 Sep 2021
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Pre-Approval Eval. of Animal Drugs and Food Additives.

    Source: FDA Data Dashboard – Inspections (FEI 1000513101, inspection ID 1155001)

  5. 10 Jul 2020
    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 1000513101, inspection ID 1124614)

  6. 09 Nov 2018
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Monitoring of Marketed Animal Drugs, Feed, and Devices.

    Source: FDA Data Dashboard – Inspections (FEI 1000513101, inspection ID 1071297)

  7. 16 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 1000513101, inspection ID 1031480)

  8. 24 Mar 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 1000513101, inspection ID 1011664)

  9. 18 Mar 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 1000513101, inspection ID 967758)

  10. 22 May 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 1000513101, inspection ID 930525)

  11. 22 May 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 1000513101, inspection ID 832603)

  12. 22 Oct 2012
    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 1000513101, inspection ID 803853)

  13. 25 May 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 1000513101, inspection ID 726275)

  14. 16 Dec 2010
    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 1000513101, inspection ID 701915)

  15. 29 Jul 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 1000513101, inspection ID 600625)

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.