# FDA 483 - Ultra Seal Corporation - November 19, 2021

Source: https://www.globalkeysolutions.net/records/483/ultra-seal-corporation/a9718a51-2146-47ef-a796-b75088a806dc

> FDA 483 for Ultra Seal Corporation on November 19, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ultra Seal Corporation
- Inspection Date: 2021-11-19
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Ultra Seal Corporation, a pharmaceutical repackager in New Paltz, NY, revealed significant deficiencies in their quality control unit, equipment cleaning validation, and discrepancy investigations. The firm failed to ensure proper stability testing and relied on non-validated test methods from a contract laboratory to release numerous drug products. Additionally, critical equipment cleaning procedures lacked validation and defined steps, and the firm failed to take market action for an out-of-specification homeopathic drug product.

## Related Documents

- [WARNING_LETTER - 2021-09-14](https://www.globalkeysolutions.net/records/warning_letter/ultra-seal-corporation/5ebe402b-ba7d-4c9e-a403-8542e6bf2368)
- [483 - 2023-09-20](https://www.globalkeysolutions.net/records/483/ultra-seal-corporation/b96689ca-b48b-452e-b179-bc1d9960f19c)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/juliana-m-badalucco/3fee9b67-1209-4f7e-8108-bd835251f6c9)
- [Consumer Safety Officer Drug Specialist](https://www.globalkeysolutions.net/people/sony-mathews/4d42379f-1245-494c-8c19-6cefa4e560a5)

Company: https://www.globalkeysolutions.net/companies/ultra-seal-corporation/cf5b79d4-f6e6-4417-82f6-2ff3c6160a3c

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