# FDA 483 - Gland Chemical Private Limited - November 17, 2025

Source: https://www.keypedia.com/records/483/gland-chemical-private-limited/600450b0-523a-4a7e-9efa-e9c71f424958

> FDA 483 for Gland Chemical Private Limited on November 17, 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: 2025-11-17
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection conducted primarily between November 17-21, 2025, at an unnamed drug manufacturing facility revealed significant deficiencies indicating a failure to adhere to Current Good Manufacturing Practices (cGMP) for sterile drug products. The observations highlight systemic concerns across critical operational and quality control areas. Key issues include a pervasive lack of adequate contamination control, with findings such as deficient segregated areas, insufficient risk assessments for potential cross-contamination involving personnel, samples, and shared facilities, and inadequate validation of sterilization processes like aseptic process simulations. Inspectors noted poor aseptic techniques during manufacturing and environmental monitoring activities, along with flawed equipment design that poses contamination risks. Furthermore, the facility demonstrated weaknesses in its quality systems and documentation. This involved discrepancies in sample collection records versus biometric access logs, inadequate laboratory control procedures (e.g., Bacterial Endotoxin Test), incomplete batch production records lacking intervention details, and insufficient controls over computer systems, including inappropriate user access. The environmental monitoring program was found to be deficient, failing to adequately assess risks from equipment and personnel, and lacking effective corrective actions for recurring excursions. Cleaning and disinfection protocols for critical areas and equipment were also deemed inadequate. The company is required to thoroughly address these observations, providing comprehensive corrective and preventive actions to ensure compliance with regulatory standards and safeguard product sterility and quality.

## Related Documents

- [483 - 2018-04-03](https://www.keypedia.com/records/483/gland-chemical-private-limited/c9e9067d-0b1a-4afe-8d2f-56a452874e70)
- [483 - 2025-11-27](https://www.keypedia.com/records/483/gland-chemical-private-limited/9fb83319-8498-422d-b8f1-e2e90a67fa18)

## Related Officers

- [Alan A. Rivera](https://www.keypedia.com/people/alan-a-rivera/4bec02c3-c62e-4b3a-a6ab-02c3386549bf)
- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)
- [Vice President Operations](https://www.keypedia.com/people/subbarao-koppula/a51a7dcc-0675-4baa-a040-905668843548)
- [Angelica M. Hernandez](https://www.keypedia.com/people/angelica-m-hernandez/d66d920c-01b6-4770-a1b5-cac9a1790a0e)

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

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