# FDA 483 - Aurobindo Pharma Limited - September 27, 2019

Source: https://www.globalkeysolutions.net/records/483/aurobindo-pharma-limited/7bfb2b5e-0991-4dcb-861b-ef0d934ade3d

> FDA 483 for Aurobindo Pharma Limited on September 27, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aurobindo Pharma Limited
- Inspection Date: 2019-09-27
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Aurobindo Pharma Limited, a finished product manufacturer in Polepally, India, was cited for significant deficiencies across its quality system. Observations included failures in out-of-specification (OOS) investigations, lack of adequate written procedures for production and process controls, and incomplete laboratory records. These issues indicate a systemic breakdown in ensuring drug product quality, identity, strength, and purity.

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## Related Officers

- [Compliance Officer at FDA](https://www.globalkeysolutions.net/people/emmanuel-j-ramos/ba0666bd-2752-453e-9fd3-5e43b1cff3ad)
- [Jogy George](https://www.globalkeysolutions.net/people/jogy-george/00ef0915-66d2-4b34-9b74-d1e08caf2db3)
- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.globalkeysolutions.net/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)

Company: https://www.globalkeysolutions.net/companies/aurobindo-pharma-limited/95bcc3b3-09a1-4249-af2f-5c83de789b76

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