# FDA 483 - Patcos Cosmetics (India) Private Limited - July 18, 2025

Source: https://www.keypedia.com/records/483/patcos-cosmetics-india-private-limited/fb84808f-8282-40b9-b397-fe54f094d85e

> FDA 483 for Patcos Cosmetics (India) Private Limited on July 18, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patcos Cosmetics (India) Private Limited
- Inspection Date: 2025-07-18
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Patcos Cosmetics (India) Private Limited, an OTC drug manufacturer in Daman, India, was cited for 17 observations during an FDA inspection. Key issues include severe data integrity concerns with altered laboratory records and torn pages, a dysfunctional quality control unit, lack of CGMP training, unvalidated analytical methods and manufacturing processes, and inadequate facility maintenance. Many of these issues were repeat observations from a previous 2023 inspection, indicating systemic and persistent non-compliance with good manufacturing practices.

## 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/patcos-cosmetics-india-private-limited/dfa98930-ce1f-45ef-8eeb-ff19abcea0c6

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