GMP Violations at Indian Facilities
Recent GMP Violations at Indian Pharma Facilities
1. Granules India (Telangana)
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In a 2024 inspection, the FDA observed severe cross-contamination issues: residues in air ducts, microbial contamination despite HEPA filters, bird droppings and feathers in production areas, and torn GMP records found in waste — all raising serious data integrity and facility maintenance concerns.
2. Eugia Pharma Specialties (Hyderabad)
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A Warning Letter dated August 2024 cited issues such as manipulated environmental monitoring data, incomplete laboratory documentation, poor cleaning and disinfection practices, and inconsistent aseptic procedures — highlighting systemic deficiencies in quality controls and CAPA effectiveness.
3. Jagsonpal Pharmaceuticals & Tyche Industries
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In early 2025, both received Warning Letters and were placed under Import Alert 66-40 due to failures in GMP:
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Jagsonpal: Lapses in process validation, analytical method validation, and refusal to permit inspection access.
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Tyche Industries: Falsified temperature data, poor cleaning procedures, and inadequate raw material testing.
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4. Kilitch Healthcare (Navi Mumbai)
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A 2024 Warning Letter recounted insanitary conditions, missing laboratory data, flawed procedures for preventing microbial contamination, and weak quality systems.
5. Natco Pharma (Telangana)
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April 2024 saw a Warning Letter for inadequate cleaning, maintenance, and sanitation — with risks of contamination and insufficient FDA response to audit findings.
6. Sun Pharma (Multiple Facilities)
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Ongoing GMP violations:
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Dadra (June 2024): Significant lapses in equipment cleaning and maintenance.
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Halol (June 2025): Eight FDA observations on cGMP violations; has been under FDA import alert since 2022
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7. Glenmark Pharmaceuticals
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In July 2025, an FDA Warning Letter cited repeated cleaning and testing failures at a facility in Madhya Pradesh — noting that similar issues across multiple sites indicate poor management oversight.
8. Historic Cases: INTA’s & Others
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Intas Pharmaceuticals: In late 2022, FDA inspectors uncovered shredded quality-control records and manipulated lab data at the Sanand plant, prompting inspections and import halts. A Redditor described the incident vividly:
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A Reddit user described an inspection report with 11 observations and 36 pages of violations!
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Ranbaxy Laboratories: Several plants were penalized over falsified data, contaminated products (e.g., hair, oil spots), and systemic GMP failures. The company ultimately pleaded guilty to felony charges in 2013.
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Overall trend: One expert noted that many warning letters relate to documentation lapses, microbial contamination, supply chain data issues, and stability testing failures.
Trends & Insights
| Trend | Insight |
|---|---|
| Widespread GMP gaps | Violations are not isolated—multiple firms across sizes and locations are affected. |
| Common deficiencies | Issues often involve data integrity failures, contamination, poor documentation, and broken quality systems. |
| Recurrence | Many companies repeat the same violations across multiple inspections and sites. |
| Impact on exports | FDA actions include Import Alerts and warning letters, threatening access to international markets. |
| Need for systemic change | Depth of issues suggests a need for stronger oversight, training, infrastructure upgrades, and cultural shifts toward quality. |
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