# FDA 483 - Glochem Industries Private Limited - June 28, 2024

Source: https://www.keypedia.com/records/483/glochem-industries-private-limited/27f9f52d-5e8e-4bc6-93c1-1b02d313ccf5

> FDA 483 for Glochem Industries Private Limited on June 28, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Glochem Industries Private Limited
- Inspection Date: 2024-06-28
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Glochem Industries Limited, an API manufacturer in Hyderabad, India, was cited for five observations during an FDA inspection. The findings indicate significant issues across quality control, manufacturing equipment maintenance, and documentation practices. These include failures in complaint investigations, equipment cleanliness, contemporaneous record-keeping, and adherence to out-of-specification procedures.

## Related Officers

- [Paranthaman Senthamarai Kannan](https://www.keypedia.com/people/paranthaman-senthamarai-kannan/12221263-b29b-4696-9e6e-84e659ae43cd)
- [S. Paranthaman](https://www.keypedia.com/people/s-paranthaman/5c0f8b8d-6490-4678-9cd9-3a2f40f4ce26)

Company: https://www.keypedia.com/companies/glochem-industries-private-limited/48a02492-47b3-4d74-af9f-fbeebb358ff7

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