# FDA 483 - Cosco Enterprises Inc. - March 26, 2024

Source: https://www.keypedia.com/records/483/cosco-enterprises-inc/ec4deb4f-bb8f-4ec1-80d0-078a7ddfb129

> FDA 483 for Cosco Enterprises Inc. on March 26, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cosco Enterprises Inc.
- Inspection Date: 2024-03-26
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Cosco Enterprises Inc., an OTC drug manufacturer in Ridgewood, NY, revealed ten significant deficiencies in their manufacturing and quality control processes for Tincture of Green Soap U.S.P. The observations highlight systemic failures in stability testing, raw material control, process validation, batch record completeness, and personnel training. Notably, several issues were repeat observations from prior inspections, indicating a lack of sustained corrective action.

## Related Officers

- [Drug Investigator](https://www.keypedia.com/people/syeda-n-mahazabin/54af6f8a-6d41-4399-b58e-a2d88fd2d7bf)

Company: https://www.keypedia.com/companies/cosco-enterprises-inc/de61210e-9051-44b4-b9de-468f8dbfd56d

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961