# FDA 483 - Orchid Pharma Ltd. - February 18, 2025

Source: https://www.globalkeysolutions.net/records/483/orchid-pharma-ltd/92c9fb4d-d10b-4574-957e-779f3f8d0427

> FDA 483 for Orchid Pharma Ltd. on February 18, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Orchid Pharma Ltd.
- Inspection Date: 2025-02-18
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Orchid Pharma Limited, an API manufacturer in Alathur, India, received a Form 483 with seven observations during an FDA inspection from February 10-18, 2025. The observations highlight significant deficiencies in cleaning validation, process validation, equipment qualification, raw material testing, cleaning procedures, data integrity for laboratory equipment, and GMP training for personnel. These issues indicate a lack of robust quality control and assurance practices impacting the quality and safety of APIs manufactured for the US market.

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)

Company: https://www.globalkeysolutions.net/companies/orchid-pharma-ltd/8fcbbb91-e867-488a-9553-608edacb945d

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