# FDA 483 - Apozeal Pharmaceuticals Inc. - April 09, 2019

Source: https://www.keypedia.com/records/483/apozeal-pharmaceuticals-inc/29de9ef7-3727-46c0-a646-f8a31f95eeb2

> FDA 483 for Apozeal Pharmaceuticals Inc. on April 09, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apozeal Pharmaceuticals Inc.
- Inspection Date: 2019-04-09
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Torrent Pharma Inc. in Levittown, PA, received an FDA Form 483 with eight observations, highlighting significant deficiencies in their quality control unit, investigation processes, and water system management. The firm failed to adequately investigate B. cepacia contamination, ensure proper cleaning validation, and maintain appropriate equipment design, leading to potential risks for distributed drug products. Several issues were repeat deficiencies, indicating persistent non-compliance.

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## Related Officers

- [Market Manager](https://www.keypedia.com/people/lisa-orr/1a0fd214-ce6e-4841-bf52-2fe4239e328a)
- [Consumer Safety Officer](https://www.keypedia.com/people/christina-k-theodorou/3c18d958-14de-4f25-9fbd-7358205155f7)
- [investigator](https://www.keypedia.com/people/dandan-wang/d305aa00-763c-4cbe-8e95-8821f7f67181)

Company: https://www.keypedia.com/companies/apozeal-pharmaceuticals-inc/0eae3e34-426a-4c5f-a067-d762962ea916

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8