# FDA 483 - Chemco Corporation - October 31, 2022

Source: https://www.globalkeysolutions.net/records/483/chemco-corporation/58f3087e-3fbd-4874-937f-28f459ba4556

> FDA 483 for Chemco Corporation on October 31, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chemco Corporation
- Inspection Date: 2022-10-31
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Chemco Corporation, a manufacturer of cosmetics and OTC drugs in Miami Lakes, FL, was cited for significant deficiencies across its laboratory, equipment, and quality systems. The inspection revealed failures in microbiological testing, inadequate laboratory data review, poorly maintained and qualified water systems, insufficient equipment cleaning verification, and a systemic failure to investigate out-of-specification results and objectionable organism findings. These issues indicate a lack of robust quality control and adherence to good manufacturing practices.

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- [483 - 2025-08-22](https://www.globalkeysolutions.net/records/483/chemco-corporation/4d7a2fea-6619-4a33-b058-8787e99493de)
- [WARNING_LETTER - 2025-08-22](https://www.globalkeysolutions.net/records/warning_letter/chemco-corporation/26e4d8d1-b21c-4d26-a56e-9cafed289568)

## Related Officers

- [Damaris Y. Hernandez](https://www.globalkeysolutions.net/people/damaris-y-hernandez/ca16093e-047b-4bf1-bcc1-c439cff21e8a)
- [Jennifer Lalama](https://www.globalkeysolutions.net/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)

Company: https://www.globalkeysolutions.net/companies/chemco-corporation/916d88f7-9782-4797-80cc-bcadd0c8915a

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6