# FDA 483 - Intermed Laboratories Private Limited - March 17, 2023

Source: https://www.keypedia.com/records/483/intermed-laboratories-private-limited/a27aefa5-46d8-442a-9d73-78d3134cb2cd

> FDA 483 for Intermed Laboratories Private Limited on March 17, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intermed Laboratories Private Limited
- Inspection Date: 2023-03-17
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Intermed, a drug manufacturer in Chennai, India, was cited for significant deficiencies in its quality control unit, including inadequate acceptance criteria for testing, lack of method validation, and insufficient in-process controls. The inspection also revealed failures in thoroughly reviewing out-of-specification results, incomplete batch production records, and inadequate storage controls for labeling materials. These issues indicate a lack of robust quality systems to ensure drug product quality and compliance.

## Related Officers

- [Alan L. Truong](https://www.keypedia.com/people/alan-l-truong/8b9c59ed-ce68-44c3-9fbe-07cc3da13713)
- [Joan M. Cantellops Figueroa](https://www.keypedia.com/people/joan-m-cantellops-figueroa/f791fcd2-a5d4-41e8-a8f2-96569096b422)

Company: https://www.keypedia.com/companies/intermed-laboratories-private-limited/20499b86-3e9e-409a-891a-3cf423a270c6

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