# FDA 483 - Emcure Pharmaceuticals Limited - February 20, 2019

Source: https://www.globalkeysolutions.net/records/483/emcure-pharmaceuticals-limited/827e00cd-a343-4d28-a7f1-e66430275403

> FDA 483 for Emcure Pharmaceuticals Limited on February 20, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Emcure Pharmaceuticals Limited
- Inspection Date: 2019-02-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Emcure Pharmaceuticals Limited in Hinjwadi, India, was cited with six observations during an FDA inspection for manufacturing sterile and non-sterile drug products. The inspection revealed significant deficiencies in quality control, aseptic processing, environmental monitoring, laboratory procedures, and record-keeping, indicating a lack of thoroughness in investigations and adherence to established protocols. These issues collectively suggest a compromised state of control over sterile manufacturing operations and data integrity.

## Related Documents

- [483 - 2015-02-04](https://www.globalkeysolutions.net/records/483/emcure-pharmaceuticals-limited/d37fce12-c463-4a2b-b90a-48faa6aba9db)
- [WARNING_LETTER - 2019-02-20](https://www.globalkeysolutions.net/records/warning_letter/emcure-pharmaceuticals-limited/f08818fe-ee88-4d41-a07d-60d67ecbb3e0)

## Related Officers

- [Chemist/Investigator - Pharmaceutical Quality](https://www.globalkeysolutions.net/people/walden-h-lee/18131eea-d1cb-47c4-af79-bea22d436031)
- [Doug Cadre](https://www.globalkeysolutions.net/people/doug-cadre/b555b16a-58e5-435c-9a46-352863b57a8c)
- [Quality System Specialist](https://www.globalkeysolutions.net/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)
- [SVP Consulting & Operations](https://www.globalkeysolutions.net/people/linda-f-murphy/a8b9737f-d5f4-4a36-8684-2fb050d008f2)

Company: https://www.globalkeysolutions.net/companies/emcure-pharmaceuticals-limited/f9f57aff-9896-431c-b393-98180a923777

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