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Gland Pharma — Hyderabad

Hyderabad, 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)
3002647489 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Hyderabad, India
Records matched
8 FDA inspections · 5 inspections with posted 483 citations
Most recent FDA inspection in dataset
25 Jul 2024 — VAI

Capabilities (from the company's website)

  • Sterile fill-finish
    …Hyderabad … Hyderabad Our 600,000 sq. ft. flagship sterile injectable facility in … Hyderabad - USFDA approved since 2003 - possesses capabilities across vari…
  • Lyophilization
    …since 2003 - possesses capabilities across various delivery formats. 6 vials lines with 7 lyophilizers: 240 million units / year & 48 million lyo units / year 1 ampoules line: 60 million un…
  • Ophthalmics
    …inges (PFS) lines -: 60 million units / year 2 Bag Filling line: 5 million units / year 1 Ophthalmic line: 45 million units / year…

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. 25 Jul 2024
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 211.180(b): Record maintenance 1 year (except exempt OTC)
    • 21 CFR 211.22(d): Procedures not in writing, fully followed

    Source: FDA Data Dashboard – Citations (FEI 3002647489, inspection ID 1244548)

  2. 25 Jul 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 3002647489, inspection ID 1244548)

  3. 14 Jul 2023
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.194(a): Complete test data included in records

    Source: FDA Data Dashboard – Citations (FEI 3002647489, inspection ID 1210381)

  4. 14 Jul 2023
    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 3002647489, inspection ID 1210381)

  5. 25 Aug 2022
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 820.30(a): Design control - no procedures

    Source: FDA Data Dashboard – Citations (FEI 3002647489, inspection ID 1179407)

  6. 25 Aug 2022
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Devices. Project area(s): Compliance: Devices.

    Source: FDA Data Dashboard – Inspections (FEI 3002647489, inspection ID 1179407)

  7. 16 May 2019
    Form 483 observations 7 posted Form 483 citation(s)

    Citation summaries (7)
    • 21 CFR 211.160(b): Scientifically sound laboratory controls
    • 21 CFR 211.192: Written record of investigation incomplete
    • 21 CFR 211.42(b): Product flow through building is inadequate
    • 21 CFR 211.42(c)(10)(iv): Environmental Monitoring System
    • 21 CFR 211.56(c): Written procedures lacking for use of pesticides etc.
    • 21 CFR 211.67(b)(2): Cleaning SOPs/schedules
    • 21 CFR 211.67(b): Written procedures fail to include

    Source: FDA Data Dashboard – Citations (FEI 3002647489, inspection ID 1090548)

  8. 16 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 3002647489, inspection ID 1090548)

  9. 03 Feb 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 3002647489, inspection ID 1002974)

  10. 17 Mar 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 3002647489, inspection ID 921536)

  11. 07 Sep 2012
    Form 483 observations 11 posted Form 483 citation(s)

    Citation summaries (11)
    • 21 CFR 211.110(a): Control procedures to monitor and validate performance
    • 21 CFR 211.113(b): Procedures for sterile drug products
    • 21 CFR 211.160(b)(3): Drug products-sampling procedures/specifications
    • 21 CFR 211.166(a): Written program not followed
    • 21 CFR 211.192: Investigations of discrepancies, failures
    • 21 CFR 211.194(a): Complete test data included in records
    • 21 CFR 211.25(a): Training , Education , Experience overall
    • 21 CFR 211.28(a): Protective Apparel Not Worn
    • 21 CFR 211.56(b): Written sanitation procedures not followed
    • 21 CFR 211.68(a): Calibration/Inspection/Checking not done
    • 21 CFR 314.81(b)(1)(ii): Contamination, chemical or physical change, deterioration

    Source: FDA Data Dashboard – Citations (FEI 3002647489, inspection ID 800507)

  12. 07 Sep 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 3002647489, inspection ID 800507)

  13. 07 Jan 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 3002647489, inspection ID 709986)

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.