# FDA 483 - Cdymax (India) Pharma Private Limited - May 17, 2019

Source: https://www.globalkeysolutions.net/records/483/cdymax-india-pharma-private-limited/6bebb67d-1710-4855-b96c-9c78b3cbb505

> FDA 483 for Cdymax (India) Pharma Private Limited on May 17, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cdymax (India) Pharma Private Limited
- Inspection Date: 2019-05-17
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Acebright (India) Pharma Private Limited, an API drug manufacturer in Jigani, India, revealed a significant deficiency in laboratory controls. The firm failed to establish scientifically sound test procedures, specifically by not using a second working standard solution during chromatographic analysis to confirm the potency, accuracy, and purity of active pharmaceutical ingredients. This indicates a serious lapse in quality control for their drug products.

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## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/gam-s-zamil/75bc04d4-6013-43b5-8200-8b513c814a7c)

Company: https://www.globalkeysolutions.net/companies/cdymax-india-pharma-private-limited/51bc8d84-9900-43c0-8e1c-9d2bd08b0ac4

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