# FDA 483 - ALMON HEALTHCARE PRIVATE LIMITED - February 13, 2026

Source: https://www.keypedia.com/records/483/almon-healthcare-private-limited/c2759c12-4255-4fca-ac2b-c7e200224b52

> FDA 483 for ALMON HEALTHCARE PRIVATE LIMITED on February 13, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ALMON HEALTHCARE PRIVATE LIMITED
- Inspection Date: 2026-02-13
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Aimon Healthcare Private Limited in Ahmedabad, India, received an FDA Form 483 citing significant deficiencies across its operations. The inspection revealed critical failures in the quality unit's oversight, including inadequate document control, lack of proper validation for test procedures, and compromised cleanroom conditions. These issues indicate a systemic breakdown in CGMP compliance, impacting active pharmaceutical ingredients (APIs) shipped to the US market.

## Related Documents

- [WARNING_LETTER - 2026-02-13](https://www.keypedia.com/records/warning_letter/almon-healthcare-private-limited/a98e75ce-315f-49ba-8585-0ca7ef652483)

## Related Officers

- [Paranthaman Senthamarai Kannan](https://www.keypedia.com/people/paranthaman-senthamarai-kannan/12221263-b29b-4696-9e6e-84e659ae43cd)
- [Paranthaman SenthamaraiKannan](https://www.keypedia.com/people/paranthaman-senthamaraikannan/8e592c88-299c-4fe5-b408-45880e6ae728)

Company: https://www.keypedia.com/companies/almon-healthcare-private-limited/5a22e478-218d-4102-848f-470ebf44ff60

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