# FDA 483 - Gasco Industrial Corp. - October 18, 2022

Source: https://www.globalkeysolutions.net/records/483/gasco-industrial-corp/679994cf-7a12-4c64-be7d-d48900201508

> FDA 483 for Gasco Industrial Corp. on October 18, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gasco Industrial Corp.
- Inspection Date: 2022-10-18
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Gasco Industrial Corp. in Gurabo, PR, was cited for significant deficiencies in its manufacturing and quality control systems for drug products like hand sanitizers and antibacterial soap. The inspection revealed failures in product testing, raw material identification, adherence to specifications, and a general lack of written procedures and facility maintenance, indicating a severe lack of GMP compliance.

## Related Documents

- [483 - 2023-12-08](https://www.globalkeysolutions.net/records/483/gasco-industrial-corp/5c2f29f8-422e-4962-8c4c-7d8a4a6d1ee1)

## Related Officers

- [Alan A. Rivera](https://www.globalkeysolutions.net/people/alan-a-rivera/4bec02c3-c62e-4b3a-a6ab-02c3386549bf)
- [Angelica M. Hernandez](https://www.globalkeysolutions.net/people/angelica-m-hernandez/d66d920c-01b6-4770-a1b5-cac9a1790a0e)
- [Retired](https://www.globalkeysolutions.net/people/ariel-cruz-figueroa/c6ade050-dbe1-4aa3-b88f-980db51b88b0)

Company: https://www.globalkeysolutions.net/companies/gasco-industrial-corp/83a607c1-89d8-46d5-8c28-791693d2495b

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6
