# FDA 483 - MSN Pharmachem Private Limited - April 21, 2023

Source: https://www.globalkeysolutions.net/records/483/msn-pharmachem-private-limited/ac452a7b-5f79-4bc4-ad43-8b00451c3b7d

> FDA 483 for MSN Pharmachem Private Limited on April 21, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MSN Pharmachem Private Limited
- Inspection Date: 2023-04-21
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: MSN Pharmachem Private Limited, an API manufacturer in Patancheru, India, was cited for deficiencies in its quality unit's written procedures and their adherence. The inspection revealed issues with market complaint investigations, including inadequate scientific justification for OOS results and failure to request customer samples, as well as a lack of written procedures for trending both regular and temporary change controls, and a failure to close minor change controls within the specified timeframe. These observations indicate a systemic weakness in the firm's quality management system.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/rachael-oyewole/bc642edb-4124-4cd1-b979-0d752ead1bfd)

Company: https://www.globalkeysolutions.net/companies/msn-pharmachem-private-limited/4fdfe142-fe56-4555-a5bc-8abd429d8e25

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