# FDA 483 - Gland Chemical Private Limited - November 27, 2025

Source: https://www.globalkeysolutions.net/records/483/gland-chemical-private-limited/9fb83319-8498-422d-b8f1-e2e90a67fa18

> FDA 483 for Gland Chemical Private Limited on November 27, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gland Chemical Private Limited
- Inspection Date: 2025-11-27
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Gland Chemicals Private Limited in Chennai, India, revealed significant deficiencies in their sterile drug manufacturing operations. The firm failed to prevent cross-contamination, adequately validate aseptic processes, maintain proper laboratory controls, and ensure data integrity. These issues indicate a high risk to the sterility and quality of their drug products.

## Related Documents

- [483 - 2018-04-03](https://www.globalkeysolutions.net/records/483/gland-chemical-private-limited/c9e9067d-0b1a-4afe-8d2f-56a452874e70)
- [483 - 2025-11-17](https://www.globalkeysolutions.net/records/483/gland-chemical-private-limited/600450b0-523a-4a7e-9efa-e9c71f424958)

## Related Officers

- [Angelica M. Hernandez](https://www.globalkeysolutions.net/people/angelica-m-hernandez/d66d920c-01b6-4770-a1b5-cac9a1790a0e)
- [Quality System Specialist](https://www.globalkeysolutions.net/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)
- [Alan A. Rivera](https://www.globalkeysolutions.net/people/alan-a-rivera/4bec02c3-c62e-4b3a-a6ab-02c3386549bf)

Company: https://www.globalkeysolutions.net/companies/gland-chemical-private-limited/a9851b78-88de-4303-8a8b-7793507fdbde

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8