# FDA 483 - Alleya Organics - July 01, 2019

Source: https://www.keypedia.com/records/483/alleya-organics/0bcaa9c2-7557-4da0-9859-fc4312d8f860

> FDA 483 for Alleya Organics on July 01, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alleya Organics
- Inspection Date: 2019-07-01
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Alleya Organics, a human OTC drug manufacturer in Yagoda, Bulgaria, was cited for four significant deficiencies during an FDA inspection. The observations highlight failures in quality control, including inadequate identity testing of active pharmaceutical ingredients, absence of a stability testing program, deficient batch production records, and lack of strict control over drug product labeling. These issues indicate a general lack of adherence to good manufacturing practices.

## Related Officers

- [Pharmaceutical Specialist/ Investigator ](https://www.keypedia.com/people/veronica-fuentes/50ea657f-39e6-4d97-a627-86339df3fbe6)

Company: https://www.keypedia.com/companies/alleya-organics/e0cbfc47-c52c-4835-a5b2-1f8d788257b1

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