# FDA 483 - OrBion Pharmaceuticals Private Limited - October 27, 2025

Source: https://www.globalkeysolutions.net/records/483/orbion-pharmaceuticals-private-limited/c77d5f8a-9fe4-4f3a-9420-8cb38c1c0df4

> FDA 483 for OrBion Pharmaceuticals Private Limited on October 27, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OrBion Pharmaceuticals Private Limited
- Inspection Date: 2025-10-27
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: OrBion Pharmaceuticals Private Limited in Sriperumbudur, India, was cited for significant deficiencies in its quality control and laboratory practices. The inspection revealed a lack of established procedures to prevent objectionable microorganisms in non-sterile drug products, leading to fungal contamination and uninvestigated microbial growth. Additionally, laboratory records were incomplete, with uncounted microbial growth and the use of defective media compromising test integrity.

## Related Documents

- [483 - 2023-09-08](https://www.globalkeysolutions.net/records/483/orbion-pharmaceuticals-private-limited/b5f7d05a-7dad-40db-95aa-7bec1c6cb422)

## Related Officers

- [Consumer Safety Officer/ Federal Investigator](https://www.globalkeysolutions.net/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)

Company: https://www.globalkeysolutions.net/companies/orbion-pharmaceuticals-private-limited/1cdc049d-587c-4283-8d5c-8604cff032c9

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