# FDA 483 - Accrete Pharmaceuticals Private Limited - May 16, 2018

Source: https://www.globalkeysolutions.net/records/483/accrete-pharmaceuticals-private-limited/fcdab759-8900-4854-8564-d316e3cc6fae

> FDA 483 for Accrete Pharmaceuticals Private Limited on May 16, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Accrete Pharmaceuticals Private Limited
- Inspection Date: 2018-05-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Accrete Pharmaceuticals Private Limited, an intermediate manufacturer in Yadadri Bhuvanagiri District, Telangana, India, revealed significant deficiencies in quality control. Observations included a lack of verification for testing methods, failures in quality unit procedures for data review and vendor qualification, and inadequate retention sample management. These issues highlight a need for improved quality system oversight and documentation.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/maria-estrella/36cf1d7d-41af-4f40-9de4-174a82a31a56)

Company: https://www.globalkeysolutions.net/companies/accrete-pharmaceuticals-private-limited/4bd5a0d1-7e01-482d-99f5-f337978ebc9b

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