# FDA 483 - Aromas Para El Alma S.A. - October 19, 2023

Source: https://www.globalkeysolutions.net/records/483/aromas-para-el-alma-sa/8cc000c8-5bad-45a0-a390-c6d8e295e050

> FDA 483 for Aromas Para El Alma S.A. on October 19, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aromas Para El Alma S.A.
- Inspection Date: 2023-10-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Aromas Para El Alma S.A., a non-sterile finished drug product manufacturer in Guachipelin, San Jose, Costa Rica, was inspected by the FDA. The inspection revealed significant deficiencies across multiple areas, including inadequate procedures for preventing microbial contamination, lack of written quality control unit responsibilities, insufficient production and process controls, unsupported expiration dates, and deficient batch records regarding component weights and yield calculations. These observations indicate a broad lack of adherence to good manufacturing practices.

## Related Documents

- [WARNING_LETTER - 2023-10-19](https://www.globalkeysolutions.net/records/warning_letter/aromas-para-el-alma-sa/ce4f1879-cb74-495b-ac99-71283d34d479)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/marcellinus-d-dordunoo/a0e35c24-0cf5-4b11-95ba-1693fa3ecb3a)

Company: https://www.globalkeysolutions.net/companies/aromas-para-el-alma-sa/e3969fd1-bc29-4e81-9462-1342e7925ff5

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