# FDA 483 - Unipharm Inc. - October 05, 2022

Source: https://www.globalkeysolutions.net/records/483/unipharm-inc/74b78188-01e7-433f-92a3-8271daf51462

> FDA 483 for Unipharm Inc. on October 05, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Unipharm Inc.
- Inspection Date: 2022-10-05
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Unipharm Inc., a drug product packager and repacker in Waterbury, CT, received a Form 483 with four observations related to significant deficiencies in their manufacturing and quality control processes. The issues include inadequate packaging process validation, unsuitable equipment design, unwritten quality control procedures, and insufficient cleaning validation for non-dedicated equipment, indicating a lack of robust controls for drug product quality and safety.

## Related Documents

- [483 - 2025-11-21](https://www.globalkeysolutions.net/records/483/unipharm-inc/09b85c95-b62f-4c70-a78d-b115b702a0ea)

## Related Officers

- [Regional Manager](https://www.globalkeysolutions.net/people/jonah-s-ufferfilge/6bcd2028-9aca-4704-bd7b-c835874fad9d)
- [Drug Investigator](https://www.globalkeysolutions.net/people/samir-c-gala/904c34ee-013d-4663-a87a-9cbdbcf2b40e)

Company: https://www.globalkeysolutions.net/companies/unipharm-inc/d5337e3f-947b-4d08-82cb-a0930e8bcdbb

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7