Directory › Alcami

Alcami — Charleston

Charleston, South Carolina, United States · CDMO

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

Site facts

Company
Alcami
Name(s) in FDA data
Alcami Carolinas Corporation
FEI number(s)
1000110990 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Charleston, South Carolina, United States 29405
Records matched
11 FDA inspections · 3 inspections with posted 483 citations
Most recent FDA inspection in dataset
22 Apr 2026 — VAI

Capabilities (from the company's website)

  • Sterile fill-finish
    …me to Alcami – Charleston, SC Campus Visitor Guide Charleston International Airport (CHS) Parenteral Manufacturing Facility 4221 Faber Place Dr., North Charleston, SC 29405 3.4 miles from Ch…

Taken from the company's web page for this site. Source: https://www.alcami.com/about-alcami/locations/charleston-sc-campus/, 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
    Form 483 observations 7 posted Form 483 citation(s)

    Citation summaries (7)
    • 21 CFR 211.100(a): Absence of Written Procedures
    • 21 CFR 211.160(a): Lab controls established, including changes
    • 21 CFR 211.192: Investigations of discrepancies, failures
    • 21 CFR 211.194(a)(8): Second person sign off
    • 21 CFR 211.194(a): Complete test data included in records
    • 21 CFR 211.22(d): Procedures not in writing, fully followed
    • 21 CFR 211.25(a): Training , Education , Experience overall

    Source: FDA Data Dashboard – Citations (FEI 1000110990, inspection ID 1313488)

  2. 22 Apr 2026
    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 1000110990, inspection ID 1313488)

  3. 06 Feb 2026
    Form 483 observations 6 posted Form 483 citation(s)

    Citation summaries (6)
    • 21 CFR 211.110(c): In-process materials characteristics testing
    • 21 CFR 211.113(b): Procedures for sterile drug products
    • 21 CFR 211.192: Investigations of discrepancies, failures
    • 21 CFR 211.42(c)(10)(iv): Environmental Monitoring System
    • 21 CFR 211.63: Equipment Design, Size and Location
    • 21 CFR 211.67(b): Written procedures fail to include

    Source: FDA Data Dashboard – Citations (FEI 1000110990, inspection ID 1301852)

  4. 06 Feb 2026
    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 1000110990, inspection ID 1301852)

  5. 05 Apr 2024
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.160(a): Following/documenting laboratory controls

    Source: FDA Data Dashboard – Citations (FEI 1000110990, inspection ID 1235733)

  6. 05 Apr 2024
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Veterinary. Project area(s): Monitoring of Marketed Animal Drugs, Feed, and Devices.

    Source: FDA Data Dashboard – Inspections (FEI 1000110990, inspection ID 1235733)

  7. 29 Oct 2021
    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 1000110990, inspection ID 1156156)

  8. 15 Mar 2018
    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 1000110990, inspection ID 1049465)

  9. 15 Dec 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 1000110990, inspection ID 1035015)

  10. 16 May 2016
    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 1000110990, inspection ID 988233)

  11. 20 Dec 2013
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Pre-Approval Eval. of Animal Drugs and Food Additives.

    Source: FDA Data Dashboard – Inspections (FEI 1000110990, inspection ID 861301)

  12. 17 May 2013
    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 1000110990, inspection ID 837471)

  13. 23 Mar 2012
    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 1000110990, inspection ID 775283)

  14. 17 Jun 2009
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Pre-Approval Eval. of Animal Drugs and Food Additives.

    Source: FDA Data Dashboard – Inspections (FEI 1000110990, inspection ID 590477)

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.