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Gland Pharma — Visakhapatnam

Visakhapatnam, India · CDMO

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

Site facts

Company
Gland Pharma
Name(s) in FDA data
Gland Pharma Limited
FEI number(s)
3009056604 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Visakhapatnam, India
Records matched
8 FDA inspections · 1 inspection with posted 483 citations
Most recent FDA inspection in dataset
28 Jul 2023 — NAI

Capabilities (from the company's website)

  • Lyophilization
    …2014, began sales in Europe in 2015 and in the United States in 2016. 3 Vial lines with 4 lyophilizers ract: 11 million units / year & 5 million lyo units / year Visakhapatnam API Facilitie…
  • API / drug substance (chemical)
    …h 4 lyophilizers ract: 11 million units / year & 5 million lyo units / year Visakhapatnam API Facilities Our 4 API manufacturing facilities have in-house manufacturing capabilities th…

Taken from the part of the company's network/locations page that describes this site. Source: https://glandpharma.com/our-capabilities/formulation-manufacturing-facilities, 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. 28 Jul 2023
    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 3009056604, inspection ID 1220251)

  2. 01 Nov 2019
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 211.113(b): Validation lacking for sterile drug products
    • 21 CFR 211.192: Written record of investigation incomplete

    Source: FDA Data Dashboard – Citations (FEI 3009056604, inspection ID 1110628)

  3. 01 Nov 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 3009056604, inspection ID 1110628)

  4. 15 Jun 2018
    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 3009056604, inspection ID 1061075)

  5. 18 May 2018
    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 3009056604, inspection ID 1056489)

  6. 31 Mar 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 3009056604, inspection ID 1010051)

  7. 30 Jun 2015
    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 3009056604, inspection ID 936901)

  8. 25 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 3009056604, inspection ID 934512)

  9. 05 Aug 2013
    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 3009056604, inspection ID 848025)

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.