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Sharp Services — Macungie

Macungie, 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)
3009566827 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Macungie, Pennsylvania, United States 18062
Records matched
6 FDA inspections · 3 inspections with posted 483 citations
Most recent FDA inspection in dataset
12 Sep 2025 — VAI

Capabilities (from the company's website)

  • Sterile fill-finish
    …harmaceutical primary and secondary packaging services including bottling, vial labeling, pre-filled syringe, autoinjector and pen assembly, cartoning and multi-component kitting. Our GMP facility o…
  • Oral solid dose
    …schedule II drug vault and III-V drug cage Contract Services Primary packaging Bottling – oral solid dose drug products Secondary packaging Vial labeling and packaging Autoinjector and pen a…
  • Clinical trial supply & packaging
    …nt Macungie, PA, US Our Macungie site specializes in pharmaceutical primary and secondary packaging services including bottling, vial labeling, pre-filled syringe, autoinjector and pen asse…

Taken from the company's web page for this site. Source: https://www.sharpservices.com/facilities/macungie-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. 12 Sep 2025
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 211.25(a): Training , Education , Experience overall
    • 21 CFR 211.67(b): Written procedures not established/followed

    Source: FDA Data Dashboard – Citations (FEI 3009566827, inspection ID 1281520)

  2. 12 Sep 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 3009566827, inspection ID 1281520)

  3. 09 Dec 2022
    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 3009566827, inspection ID 1194346)

  4. 16 Aug 2018
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.192: Investigations of discrepancies, failures

    Source: FDA Data Dashboard – Citations (FEI 3009566827, inspection ID 1063206)

  5. 16 Aug 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 3009566827, inspection ID 1063206)

  6. 10 May 2016
    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 3009566827, inspection ID 971951)

  7. 25 Feb 2014
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.22(d): Procedures not in writing, fully followed

    Source: FDA Data Dashboard – Citations (FEI 3009566827, inspection ID 867425)

  8. 25 Feb 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 3009566827, inspection ID 867425)

  9. 10 Oct 2012
    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 3009566827, inspection ID 803256)

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.