# FDA 483 - FANCYSTAGE, UNIPESSOAL, LDA. - January 26, 2024

Source: https://www.globalkeysolutions.net/records/483/fancystage-unipessoal-lda/aae50d33-8584-414b-845d-c6a34045b72e

> FDA 483 for FANCYSTAGE, UNIPESSOAL, LDA. on January 26, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FANCYSTAGE, UNIPESSOAL, LDA.
- Inspection Date: 2024-01-26
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: FANCYSTAGE, UNIPESSOAL, LDA., an OTC drug manufacturer in Trofa, Portugal, received a Form FDA 483 with seven observations during an inspection from January 22-26, 2024. The observations highlight significant deficiencies in production and process controls, equipment cleaning and validation, stability testing, OOS investigations, test method validation, quality control unit responsibilities, and labeling/packaging material procedures. These issues indicate a broad lack of established and followed written procedures essential for ensuring drug product quality and safety.

## Related Officers

- [Bijoy Panicker](https://www.globalkeysolutions.net/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)

Company: https://www.globalkeysolutions.net/companies/fancystage-unipessoal-lda/dfa84377-ba81-4b38-be0b-b803c97b2526

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1