Directory › Bend Bioscience (formerly Societal CDMO)

Bend Bioscience (formerly Societal CDMO) — Gainesville

Gainesville, Georgia, United States · CDMO

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

Site facts

Company
Bend Bioscience (formerly Societal CDMO)
Name(s) in FDA data
Societal CDMO Gainesville, LLC
FEI number(s)
1035761 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Gainesville, Georgia, United States 30504
Records matched
7 FDA inspections · 2 inspections with posted 483 citations
Most recent FDA inspection in dataset
19 Nov 2024 — VAI

Capabilities (from the company's website)

  • Oral solid dose
    …Gainesville, Georgia Our Gainesville, GA sites specialize in oral solid dosage forms, particularly modified release, multiparticulates, and coating. We boast a l…

Taken from the part of the company's network/locations page that describes this site. Source: https://bendbioscience.com/locations, 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. 19 Nov 2024
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.68(b): Computer control of master formula records

    Source: FDA Data Dashboard – Citations (FEI 1035761, inspection ID 1254528)

  2. 19 Nov 2024
    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 1035761, inspection ID 1254528)

  3. 24 Jan 2018
    Form 483 observations 4 posted Form 483 citation(s)

    Citation summaries (4)
    • 21 CFR 211.194(a)(8): Second person sign off
    • 21 CFR 211.194(a): Complete test data included in records
    • 21 CFR 211.67(a): Cleaning / Sanitizing / Maintenance
    • 21 CFR 211.68(b): Computer control of master formula records

    Source: FDA Data Dashboard – Citations (FEI 1035761, inspection ID 1038575)

  4. 24 Jan 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 1035761, inspection ID 1038575)

  5. 31 Jan 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 1035761, inspection ID 1019509)

  6. 18 Mar 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 1035761, inspection ID 870449)

  7. 17 Nov 2011
    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 1035761, inspection ID 755767)

  8. 21 Dec 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 1035761, inspection ID 703564)

  9. 24 Mar 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 1035761, inspection ID 654260)

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.