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

Source: https://www.keypedia.com/records/483/msn-pharmachem-private-limited/61267a10-6a0b-4baa-9896-fc13427a898b

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

---

## Details

- Record Type: 483
- Company Name: MSN Pharmachem Private Limited
- Inspection Date: 2023-04-21
- Product Type: drugs
- Office Name: Food and Drug Administration
- Summary: An FDA inspection conducted at MSN Pharmachem Private Limited from April 17 to April 21, 2023, revealed significant deficiencies within the company's quality unit. The Active Pharmaceutical Ingredient (API) manufacturer, located in Patancheru, India, received a Form FDA 483 detailing observations primarily concerning the inadequacy of written procedures and a failure to consistently follow established quality protocols. Key issues included a lack of scientific justification in market complaint investigations, where out-of-specification results were sometimes incorrectly labeled as acceptable. The firm's procedures also failed to adequately define when customer samples should be requested during complaint reviews. Furthermore, the company lacked written procedures for effectively trending both standard and temporary change controls, which are critical for monitoring modifications to manufacturing processes or systems. A notable observation was the failure to adhere to the firm's own change control management procedures; minor changes were not closed within the specified timeframe. One instance showed a minor change control remaining open for an excessive period of approximately 1043 days, far exceeding the internal deadline. These observations indicate a need for improved adherence to regulatory requirements and quality system standards. MSN Pharmachem Private Limited is expected to submit a thorough response outlining corrective and preventive actions to rectify these issues and ensure ongoing compliance.

## Related Documents

- [483 - 2023-04-21](https://www.keypedia.com/records/483/msn-pharmachem-private-limited/ac452a7b-5f79-4bc4-ad43-8b00451c3b7d)

## Related Officers

- [Dustin O. Neilson](https://www.keypedia.com/people/dustin-o-neilson/2dfa6146-d08b-4ab6-ae83-7b76bd943158)

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

Office: https://www.keypedia.com/offices/food-and-drug-administration/437fdb2a-5048-42aa-aaea-ea28efe65516