# FDA 483 - RemedyRepack Inc. - April 14, 2025

Source: https://www.keypedia.com/records/483/remedyrepack-inc/4bbf7849-d81d-4d6b-8179-f9b9ba3293dc

> FDA 483 for RemedyRepack Inc. on April 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RemedyRepack Inc.
- Inspection Date: 2025-04-14
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: RemedyRePack Inc., a drug repacker and relabeler in Indiana, PA, received seven observations during an FDA inspection from April 8-14, 2025. The firm was cited for significant deficiencies in its quality control and production processes, including a repeat observation regarding packaging process validation. Key issues include inadequate written procedures for critical operations, poor labeling controls, and failure to maintain equipment cleanliness and proper drug storage conditions.

## Related Documents

- [483 - 2022-11-10](https://www.keypedia.com/records/483/remedyrepack-inc/7643db5a-88a8-42c0-81f4-05464ba24b16)

## Related Officers

- [Investigator](https://www.keypedia.com/people/karen-a-briggs/3e77d364-25ea-48c7-87f4-36f3e170bfb5)
- [Kara J. Wright](https://www.keypedia.com/people/kara-j-wright/d12b6a4f-9710-4811-b1b2-5ff5f9342155)

Company: https://www.keypedia.com/companies/remedyrepack-inc/a3dc0eee-e83e-497e-b124-a442efcaeb88

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