# FDA 483 - Biocon Biosphere Limited - November 07, 2025

Source: https://www.keypedia.com/records/483/biocon-biosphere-limited/303b1312-0294-4597-88e2-3746045dfd99

> FDA 483 for Biocon Biosphere Limited on November 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biocon Biosphere Limited
- Inspection Date: 2025-11-07
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Biocon Biosphere Limited, a drug substance manufacturer, was inspected and cited for two significant observations. The firm failed to establish appropriate qualifications and controls for computerized systems, specifically regarding the validation and control of electronic master batch records. Additionally, written procedures for equipment cleaning were found to be inadequately described or followed, with cleaning limits lacking scientific justification and deficiencies in swab sampling methods.

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## Related Officers

- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)

Company: https://www.keypedia.com/companies/biocon-biosphere-limited/4c5f824e-c399-4c0e-91be-45739741dc2c

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8