# FDA 483 - Biocosmetica Excel Argentina S.R.L. - July 07, 2022

Source: https://www.keypedia.com/records/483/biocosmetica-excel-argentina-srl/284e2cfc-7529-4b13-bfdf-467d8944f7bb

> FDA 483 for Biocosmetica Excel Argentina S.R.L. on July 07, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biocosmetica Excel Argentina S.R.L.
- Inspection Date: 2022-07-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Biocosmetica Excel Argentina S.R.L., an OTC drug manufacturer in San Justo, Argentina, was cited for multiple deficiencies during an FDA inspection. The observations primarily concern inadequate laboratory controls, insufficient component testing, lack of validation for computer systems and equipment, and absent or deficient written procedures for quality systems, production records, and equipment maintenance. These issues indicate a general lack of adherence to good manufacturing practices.

## Related Officers

- [Investigator](https://www.keypedia.com/people/kham-phommachanh/cc7e728e-d2a1-469d-be3a-4f5fdd43b2dc)

Company: https://www.keypedia.com/companies/biocosmetica-excel-argentina-srl/563d291f-a790-4104-8542-a07f917e3e32

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