# FDA 483 - Blossom Pharmaceuticals - April 11, 2025

Source: https://www.keypedia.com/records/483/blossom-pharmaceuticals/0d392295-6aa6-4e44-ac26-1d7eb1438b92

> FDA 483 for Blossom Pharmaceuticals on April 11, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Blossom Pharmaceuticals
- Inspection Date: 2025-04-11
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Blossom Pharmaceuticals, an OTC drug manufacturer in Bardez, Goa, India, received a Form 483 for significant GMP deficiencies. The inspection revealed systemic failures in data integrity, process and cleaning validation, equipment maintenance, laboratory controls, environmental conditions, quality unit oversight, and personnel training. These issues indicate a profound lack of control over manufacturing processes and product quality.

## Related Officers

- [Investigator](https://www.keypedia.com/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)

Company: https://www.keypedia.com/companies/blossom-pharmaceuticals/14aebe73-3f72-4eab-8ca2-6e16c3262b19

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