# FDA 483 - Gland Chemical Private Limited - April 03, 2018

Source: https://www.globalkeysolutions.net/records/483/gland-chemical-private-limited/c9e9067d-0b1a-4afe-8d2f-56a452874e70

> FDA 483 for Gland Chemical Private Limited on April 03, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gland Chemical Private Limited
- Inspection Date: 2018-04-03
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: This 483 report for Hospira Healthcare India Pvt. Ltd. details significant quality control and manufacturing deficiencies. The firm failed to ensure cGMP compliance, manipulated laboratory data, and released drug products that did not meet specifications. Repeated observations from previous inspections indicate a systemic lack of adequate investigation, process control, and method validation, leading to distributed out-of-specification products and potential patient safety risks.

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- [483 - 2025-11-17](https://www.globalkeysolutions.net/records/483/gland-chemical-private-limited/600450b0-523a-4a7e-9efa-e9c71f424958)
- [483 - 2025-11-27](https://www.globalkeysolutions.net/records/483/gland-chemical-private-limited/9fb83319-8498-422d-b8f1-e2e90a67fa18)

## Related Officers

- [Quality System Specialist](https://www.globalkeysolutions.net/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)
- [Ademola O. Daramola](https://www.globalkeysolutions.net/people/ademola-o-daramola/814113a4-38bc-4ce5-b6af-09c7e688c0ec)

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

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1