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Aenova — Latina

Latina, Italy · CDMO

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

Site facts

Company
Aenova
Name(s) in FDA data
Haupt Pharma Latina Srl
FEI number(s)
3007687501 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Latina, Italy
Records matched
8 FDA inspections · 2 inspections with posted 483 citations
Most recent FDA inspection in dataset
11 Apr 2025 — VAI

Capabilities (from the company's website)

  • Sterile fill-finish
    …strategic investments we enhance capacity and capabilities in the site, e.g. with the new Fill&Finish Suite for PFS and Vials for small molecules API and large molecules Biologics. The site i…
  • Small molecule
    …he world for human and veterinary use. Covered business segments are F&F of Biologics and Small Molecules Betalactam Sterile Fillings Penicillins Oral Solids Conventional Oral Solids Oral Solid P…
  • API / drug substance (chemical)
    …es in the site, e.g. with the new Fill&Finish Suite for PFS and Vials for small molecules API and large molecules Biologics. The site in Latina is one of the largest production facili…
  • Oral solid dose
    …segments are F&F of Biologics and Small Molecules Betalactam Sterile Fillings Penicillins Oral Solids Conventional Oral Solids Oral Solid Parasiticides With many strategic investments we enh…
  • Clinical trial supply & packaging
    …atory support Testing and EU batch release Dossier writing and update Artwork development Packaging Services Full capabilities for: Plastic syringes PFS Vials Bottles Blisters Sachets Repac…
  • Analytical testing
    …ory services Quality services Development Services Technology transfer Project management Analytical methods Stability studies (ICH program) Engineering service Process validation/qualification Pro…
  • Microbiology
    …ds sterile fill & finish manufacturing capacity at its Latina site 10.09.2025 New 800 sqm microbiology quality laboratory at Aenova Latina site bolsters sterile capabilities 27.06.2025 Aenova…

Taken from the company's web page for this site. Source: https://www.aenova-group.com/en/company/manufacturing-sites/latina, 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. 11 Apr 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 3007687501, inspection ID 1330406)

  2. 21 Feb 2024
    FDA inspection FDA inspection classified OAI

    Official Action Indicated (OAI). Product type(s): Veterinary. Project area(s): Pre-Approval Eval. of Animal Drugs and Food Additives.

    Source: FDA Data Dashboard – Inspections (FEI 3007687501, inspection ID 1237210)

  3. 29 Jul 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 3007687501, inspection ID 1206882)

  4. 28 Jun 2018
    Form 483 observations 5 posted Form 483 citation(s)

    Citation summaries (5)
    • 21 CFR 211.113(b): Procedures for sterile drug products
    • 21 CFR 211.160(b): Scientifically sound laboratory controls
    • 21 CFR 211.22(a): Approve or reject components, products
    • 21 CFR 211.25(a): Training , Education , Experience overall
    • 21 CFR 211.58: Buildings not maintained in good state of repair

    Source: FDA Data Dashboard – Citations (FEI 3007687501, inspection ID 1059418)

  5. 28 Jun 2018
    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 3007687501, inspection ID 1059418)

  6. 16 Dec 2016
    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 3007687501, inspection ID 1004993)

  7. 04 Nov 2014
    Form 483 observations 6 posted Form 483 citation(s)

    Citation summaries (6)
    • 21 CFR 211.113(a): Procedures for non-sterile drug products
    • 21 CFR 211.160(a): Following/documenting laboratory controls
    • 21 CFR 211.52: Washing and toilet facilities are deficient
    • 21 CFR 211.58: Buildings not maintained in good state of repair
    • 21 CFR 211.67(a): Cleaning / Sanitizing / Maintenance
    • 21 CFR 211.67(b): Written procedures not established/followed

    Source: FDA Data Dashboard – Citations (FEI 3007687501, inspection ID 908678)

  8. 04 Nov 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 3007687501, inspection ID 908678)

  9. 12 Dec 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 3007687501, inspection ID 812047)

  10. 13 Oct 2009
    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 3007687501, inspection ID 624989)

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.