# FDA 483 - Ultra Seal Corporation - September 20, 2023

Source: https://www.globalkeysolutions.net/records/483/ultra-seal-corporation/b96689ca-b48b-452e-b179-bc1d9960f19c

> FDA 483 for Ultra Seal Corporation on September 20, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ultra Seal Corporation
- Inspection Date: 2023-09-20
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Ultra Seal Corporation, a pharmaceutical packager in New Paltz, NY, received a Form 483 with five observations highlighting significant deficiencies in their quality control unit, equipment cleaning and validation, manufacturing process controls, and storage conditions. Key issues include a lack of stability testing, unvalidated test methods, inadequate equipment cleaning procedures, unperformed equipment and packaging validations, and unmonitored warehouse temperatures. These findings indicate a systemic failure to adhere to cGMP requirements, with some issues being repeat observations.

## Related Documents

- [483 - 2021-11-19](https://www.globalkeysolutions.net/records/483/ultra-seal-corporation/a9718a51-2146-47ef-a796-b75088a806dc)
- [WARNING_LETTER - 2021-09-14](https://www.globalkeysolutions.net/records/warning_letter/ultra-seal-corporation/5ebe402b-ba7d-4c9e-a403-8542e6bf2368)

## Related Officers

- [Ruben C. Quintana](https://www.globalkeysolutions.net/people/ruben-c-quintana/fbf0f0ef-eb51-4a06-a4b9-f7856fa06c58)
- [Drug Investigator](https://www.globalkeysolutions.net/people/syeda-n-mahazabin/54af6f8a-6d41-4399-b58e-a2d88fd2d7bf)
- [Tanya R. Syffrard](https://www.globalkeysolutions.net/people/tanya-r-syffrard/a78a42b3-6cef-46d9-9698-ec6082956477)

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