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Sharp Services — Allentown

Allentown, Pennsylvania, United States · CDMO

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

Site facts

Company
Sharp Services
Name(s) in FDA data
Sharp Packaging Services, LLC
FEI number(s)
3004161147 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Allentown, Pennsylvania, United States 18106
Records matched
12 FDA inspections · 2 inspections with posted 483 citations
Most recent FDA inspection in dataset
22 Apr 2026 — NAI

Capabilities (from the company's website)

  • Oral solid dose
    …dministration (DEA) schedule II drug vault Contract Services Primary packaging Bottling – oral solid dose drug products Pouching – solid dose, powder Secondary packaging Cartoning and kittin…
  • Clinical trial supply & packaging
    …ontent Allentown, PA, US - Building 1 The global headquarters of Sharp, and our Specialty Packaging Center of Excellence, is located at our Allentown campus and offers a breadth of primary…

Taken from the company's web page for this site. Source: https://www.sharpservices.com/facilities/building-1-allentown-us/, 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. 22 Apr 2026
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Biologics. Project area(s): Vaccines and Allergenic Products.

    Source: FDA Data Dashboard – Inspections (FEI 3004161147, inspection ID 1314200)

  2. 21 Nov 2025
    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 3004161147, inspection ID 1283904)

  3. 28 Jan 2022
    Form 483 observations 13 posted Form 483 citation(s)

    Citation summaries (13)
    • 21 CFR 211.103: Actual vs. theoretical yields not determined
    • 21 CFR 211.110(a): Control procedures to monitor and validate performance
    • 21 CFR 211.125(d): Destruction of excess labels with lot numbers
    • 21 CFR 211.130(e): Packaging line inspection before use
    • 21 CFR 211.142: Written warehousing procedures established/followed
    • 21 CFR 211.188(a): Accurate reproduction
    • 21 CFR 211.192: Written record of investigation incomplete
    • 21 CFR 211.198(b)(2): Complaint Investigation/Follow-Up Findings
    • 21 CFR 211.22(a): Approve or reject components, products
    • 21 CFR 211.22(d): Procedures not in writing, fully followed
    • 21 CFR 211.42(a): Buildings of Suitable Size, Construction, Location
    • 21 CFR 211.63: Equipment Design, Size and Location
    • 21 CFR 211.68(b): Backup file not maintained

    Source: FDA Data Dashboard – Citations (FEI 3004161147, inspection ID 1161256)

  4. 28 Jan 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 3004161147, inspection ID 1161256)

  5. 24 Apr 2019
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.184(b): Component Test Records

    Source: FDA Data Dashboard – Citations (FEI 3004161147, inspection ID 1087516)

  6. 24 Apr 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 3004161147, inspection ID 1087516)

  7. 13 Aug 2018
    FDA inspection FDA inspection classified NAI

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

    Source: FDA Data Dashboard – Inspections (FEI 3004161147, inspection ID 1070357)

  8. 03 Feb 2017
    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 3004161147, inspection ID 1002333)

  9. 19 Jun 2014
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Devices. Project area(s): Project Evaluation: Devices.

    Source: FDA Data Dashboard – Inspections (FEI 3004161147, inspection ID 883821)

  10. 15 Jan 2014
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs, Food/Cosmetics, Veterinary. Project area(s): Drug Quality Assurance; Food Composition, Standards, Labeling and Econ; Monitoring of Marketed Animal Drugs, Feed, and Devices.

    Source: FDA Data Dashboard – Inspections (FEI 3004161147, inspection ID 862935)

  11. 21 Feb 2013
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Devices. Project area(s): Compliance: Devices.

    Source: FDA Data Dashboard – Inspections (FEI 3004161147, inspection ID 820216)

  12. 23 Jan 2012
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Devices. Project area(s): Compliance: Devices; Postmarket Assurance: Devices.

    Source: FDA Data Dashboard – Inspections (FEI 3004161147, inspection ID 763030)

  13. 13 Apr 2011
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs, Food/Cosmetics, Veterinary. Project area(s): Drug Quality Assurance; Food Composition, Standards, Labeling and Econ; Monitoring of Marketed Animal Drugs, Feed, and Devices.

    Source: FDA Data Dashboard – Inspections (FEI 3004161147, inspection ID 719565)

  14. 29 Jul 2009
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Food/Cosmetics. Project area(s): Food Composition, Standards, Labeling and Econ; Foodborne Biological Hazards.

    Source: FDA Data Dashboard – Inspections (FEI 3004161147, inspection ID 618027)

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.