# FDA 483 - Chemspec Chemicals Private Limited - August 01, 2025

Source: https://www.keypedia.com/records/483/chemspec-chemicals-private-limited/e0c9e917-1732-4684-8ee5-70122ad1e92d

> FDA 483 for Chemspec Chemicals Private Limited on August 01, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chemspec Chemicals Private Limited
- Inspection Date: 2025-08-01
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of Chemspec Chemicals Private Limited, an API manufacturer in Navi Mumbai, India, revealed significant deficiencies across multiple areas. The firm failed to maintain adequate batch records, control document issuance, ensure proper quality unit oversight, validate test procedures for raw materials, conduct thorough investigations, and contemporaneously record quality-related activities. Additionally, cleaning procedures and their documentation were found to be deficient.

## Related Officers

- [Paranthaman Senthamarai Kannan](https://www.keypedia.com/people/paranthaman-senthamarai-kannan/12221263-b29b-4696-9e6e-84e659ae43cd)
- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.keypedia.com/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)

Company: https://www.keypedia.com/companies/chemspec-chemicals-private-limited/ec93b908-bed8-4233-a82b-159c8051fb0a

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3