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Piramal Pharma Solutions — Lexington

Lexington, Kentucky, United States · CDMO

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

Site facts

Company
Piramal Pharma Solutions
Name(s) in FDA data
Piramal Pharma Solutions Inc.
FEI number(s)
3006419237 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Lexington, Kentucky, United States 40511
Records matched
10 FDA inspections · 2 inspections with posted 483 citations
Most recent FDA inspection in dataset
10 Dec 2025 — VAI

Capabilities (from the company's website)

  • Sterile fill-finish
    …KY Driving Distance: Approx 77 miles (70 min) Formulation Development & Manufacturing of Sterile Injectables Piramal's Lexington, KY site specializes in the formulation development and manufacturin…
  • Lyophilization
    …and manufacturing of Sterile Injectables, offering sterile compounding, fill/finish, and lyophilization capabilities. The facility is equipped with in-house analytical, microbiological, fo…
  • API / drug substance (chemical)
    …l products with very low Occupational Exposure Limit (OEL) values, including high potency APIs, cytotoxic agents, hormones, and steroids. We offer vial capabilities ranging from 2 mL t…
  • Highly potent (HPAPI)
    …and lyophilized formulations. Site Capabilities Isolator-based Technology Lyophilization Potent Compounds Liposomal Formulations Analytical and Microbiological Method Development Isolator-based…
  • ADCs & bioconjugates
    …uch as Liposomal, Nano-emulsions, Nanoparticle suspensions and Anti-body Drug Conjugates (ADCs). Major regulatory accreditations include USFDA, PMDA, TFDA and Saudi Food and Drug Autho…
  • Analytical testing
    …cycle development, material compatibility studies, filter selection, and in-use solution stability studies. Formulation Development arrow_outward Clinical and Commercial Manufacturing Our manufact…
  • Microbiology
    …nish, and lyophilization capabilities. The facility is equipped with in-house analytical, microbiological, formulation development, and manufacturing services, spanning from preclinical to cl…
  • Solid-state & particle characterization
    …y formulations, with rigorous in-process testing to ensure maximum encapsulation, correct particle size distribution, optimal lipid concentration, and low bioburden. Our batch size capabilities…
  • Formulation & process development
    …ntucky International Airport (CVG), Hebron, KY Driving Distance: Approx 77 miles (70 min) Formulation Development & Manufacturing of Sterile Injectables Piramal's Lexington, KY site specializes in the fo…

Taken from the company's web page for this site. Source: https://www.piramalpharmasolutions.com/facilities/sterile-injectables-development-and-manufacturing-lexington, 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. 10 Dec 2025
    Form 483 observations 4 posted Form 483 citation(s)

    Citation summaries (4)
    • 21 CFR 211.100(a): Absence of Written Procedures
    • 21 CFR 211.113(b): Procedures for sterile drug products
    • 21 CFR 211.192: Investigations of discrepancies, failures
    • 21 CFR 211.68(b): Computer control of master formula records

    Source: FDA Data Dashboard – Citations (FEI 3006419237, inspection ID 1295282)

  2. 10 Dec 2025
    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 3006419237, inspection ID 1295282)

  3. 23 Feb 2024
    FDA inspection FDA inspection classified VAI

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

    Source: FDA Data Dashboard – Inspections (FEI 3006419237, inspection ID 1230838)

  4. 10 Jan 2023
    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 3006419237, inspection ID 1195318)

  5. 11 Apr 2019
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). 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 3006419237, inspection ID 1090150)

  6. 14 Mar 2018
    Form 483 observations 6 posted Form 483 citation(s)

    Citation summaries (6)
    • 21 CFR 211.165(e): Test methods
    • 21 CFR 211.194(a)(5): Testing Calculations
    • 21 CFR 211.22(d): Procedures not in writing, fully followed
    • 21 CFR 211.42(c)(10)(v): Cleaning System
    • 21 CFR 211.68(b): Computer control of master formula records
    • 21 CFR 211.84(e): Rejecting When Specifications Not Met

    Source: FDA Data Dashboard – Citations (FEI 3006419237, inspection ID 1044232)

  7. 14 Mar 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 3006419237, inspection ID 1044232)

  8. 14 Apr 2016
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Veterinary. Project area(s): Monitoring of Marketed Animal Drugs, Feed, and Devices.

    Source: FDA Data Dashboard – Inspections (FEI 3006419237, inspection ID 973534)

  9. 17 Apr 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 3006419237, inspection ID 883660)

  10. 15 Apr 2014
    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 3006419237, inspection ID 883657)

  11. 27 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 3006419237, inspection ID 570441)

  12. 13 Feb 2009
    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 3006419237, inspection ID 571861)

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.