# FDA 483 - Centaur Pharmaceuticals Private Ltd. - July 25, 2025

Source: https://www.globalkeysolutions.net/records/483/centaur-pharmaceuticals-private-ltd/6c217560-02bc-4554-9c90-7d29e514896c

> FDA 483 for Centaur Pharmaceuticals Private Ltd. on July 25, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Centaur Pharmaceuticals Private Ltd.
- Inspection Date: 2025-07-25
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Centaur Pharmaceuticals Private Limited, a drug substance manufacturer in Ambernath (W), India, was cited for significant deficiencies during an FDA inspection. Observations included inadequate Out-of-Specification (OOS) investigations, a deficient stability monitoring program, and insufficient process validations. These issues led to the distribution of API batches without proper stability data or adequate process controls.

## Related Documents

- [483 - 2022-11-21](https://www.globalkeysolutions.net/records/483/centaur-pharmaceuticals-private-ltd/4a591dbb-e749-4fd1-9802-57abaa2496e6)

## Related Officers

- [Paranthaman Senthamarai Kannan](https://www.globalkeysolutions.net/people/paranthaman-senthamarai-kannan/12221263-b29b-4696-9e6e-84e659ae43cd)
- [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/centaur-pharmaceuticals-private-ltd/f96f4f92-5b20-4b5d-91d8-5b0dbe430494

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