Directory › Unither Pharmaceuticals

Unither Pharmaceuticals — Rochester

Rochester, New York, United States · CDMO

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

Site facts

Company
Unither Pharmaceuticals
Name(s) in FDA data
Unither Manufacturing LLC.
FEI number(s)
1314625 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Rochester, New York, United States 14623
Records matched
8 FDA inspections · 4 inspections with posted 483 citations
Most recent FDA inspection in dataset
15 May 2026 — OAI

Capabilities (from the company's website)

  • Sterile fill-finish
    …n Monroe County, New York, the Rochester site develops and manufactures preservative-free sterile liquid forms (BFS), oral and topical stick packs, pharmaceutical bottles, and controlled substan…
  • Oral liquids & semi-solids
    …ter site develops and manufactures preservative-free sterile liquid forms (BFS), oral and topical stick packs, pharmaceutical bottles, and controlled substances. Rochester is a land of en…
  • Inhalation & nasal
    …ly manufactured products Sterile single doses (Blow-Fill-Seal): ophthalmology, rhinology, inhalation, antisepsis, ENT Liquid stick packs: oral and topical routes Pharmaceutical bottles:…
  • Analytical testing
    …ctured for our clients are distributed Expertise and know-how Development Formulation and analytical development, manufacture of clinical batches, stability studies, and expertise in ophthalmic developm…
  • Controlled substances
    …ree sterile liquid forms (BFS), oral and topical stick packs, pharmaceutical bottles, and controlled substances. Rochester is a land of engineers and innovators. This spirit is reflected in every prod…
  • Ophthalmics
    …lytical development, manufacture of clinical batches, stability studies, and expertise in ophthalmic development. Analytical Development The entire development and production cycle: from for…

Taken from the company's web page for this site. Source: https://www.unither-pharma.com/site/rochester/, 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. 15 May 2026
    Form 483 observations 9 posted Form 483 citation(s)

    Citation summaries (9)
    • 21 CFR 211.113(b): Procedures for sterile drug products
    • 21 CFR 211.142(b): Storage under appropriate conditions
    • 21 CFR 211.160(b): Scientifically sound laboratory controls
    • 21 CFR 211.165(b): Microbiological testing
    • 21 CFR 211.165(d): Acceptance criteria for sampling & testing
    • 21 CFR 211.166(a): Lack of written stability program
    • 21 CFR 211.22(d): Procedures not in writing, fully followed
    • 21 CFR 211.67(b): Written procedures not established/followed
    • 21 CFR 211.68(b): input/output verification

    Source: FDA Data Dashboard – Citations (FEI 1314625, inspection ID 1320018)

  2. 15 May 2026
    FDA inspection FDA inspection classified OAI

    Official Action Indicated (OAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 1314625, inspection ID 1320018)

  3. 15 Oct 2021
    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 1314625, inspection ID 1155229)

  4. 22 May 2019
    Form 483 observations 3 posted Form 483 citation(s)

    Citation summaries (3)
    • 21 CFR 211.188(b)(2): Identity of major equipment and lines used
    • 21 CFR 211.192: Investigations of discrepancies, failures
    • 21 CFR 211.67(a): Cleaning / Sanitizing / Maintenance

    Source: FDA Data Dashboard – Citations (FEI 1314625, inspection ID 1090360)

  5. 22 May 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 1314625, inspection ID 1090360)

  6. 01 Mar 2017
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 211.28(a): Protective Apparel Not Worn
    • 21 CFR 211.67(a): Cleaning / Sanitizing / Maintenance

    Source: FDA Data Dashboard – Citations (FEI 1314625, inspection ID 1003363)

  7. 01 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 1314625, inspection ID 1003363)

  8. 01 Jun 2015
    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 1314625, inspection ID 928559)

  9. 15 Jun 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 1314625, inspection ID 788511)

  10. 23 Nov 2010
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 211.67(b): Written procedures fail to include
    • 21 CFR 211.68(b): input/output verification

    Source: FDA Data Dashboard – Citations (FEI 1314625, inspection ID 703101)

  11. 23 Nov 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 1314625, inspection ID 703101)

  12. 19 Jan 2010
    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 1314625, inspection ID 634823)

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.