# FDA 483 - Gland Chemical Private Limited - Unknown Date

Source: https://www.keypedia.com/records/483/gland-chemical-private-limited/9db716f5-9bed-4f10-a466-30b4c43e6fdb

> FDA 483 for Gland Chemical Private Limited on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gland Chemical Private Limited
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Pfizer Healthcare India Private Limited in Waluj, India, was inspected and cited for multiple deficiencies related to quality unit oversight, material control, stability data, production records, equipment qualification, and laboratory controls. The observations indicate a lack of robust quality systems, potentially impacting the quality and purity of active pharmaceutical ingredients. This suggests significant concerns regarding the firm's adherence to good manufacturing practices.

## Related Documents

- [483 - 2018-08-07](https://www.keypedia.com/records/483/gland-chemical-private-limited/d005a6db-331a-4f74-84e8-82eacbbc29dc)

## Related Officers

- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)
- [SVP Consulting & Operations](https://www.keypedia.com/people/linda-f-murphy/a8b9737f-d5f4-4a36-8684-2fb050d008f2)

Company: https://www.keypedia.com/companies/gland-chemical-private-limited/a892a657-c448-45cc-9b80-3284cd941dda

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