# FDA 483 - MSN Laboratories Private Ltd. - June 23, 2016

Source: https://www.globalkeysolutions.net/records/483/msn-laboratories-private-ltd/b1bf84da-4acd-4e7e-af4a-f75dea2a3e1d

> FDA 483 for MSN Laboratories Private Ltd. on June 23, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MSN Laboratories Private Ltd.
- Inspection Date: 2016-06-23
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: MSN Laboratories Private Limited in Telangana, India, an Active Pharmaceutical Ingredient (API) manufacturer, was cited for significant quality system deficiencies. Observations included a failure to investigate numerous instances of invalid HPLC/GC analysis and reprocessed chromatograms, as well as inadequate control over temperature-sensitive raw materials. Additionally, the firm failed to ensure appropriate transport and storage conditions for APIs shipped internationally to the US market.

## Related Officers

- [Microbiologist ](https://www.globalkeysolutions.net/people/doan-t-nguyen/2b1112b4-01b8-4581-82f2-86cbe29c8857)

Company: https://www.globalkeysolutions.net/companies/msn-laboratories-private-ltd/c72800c4-c988-4f52-be08-6bcf51eed33d

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd