# FDA 483 - RemedyRepack Inc. - November 10, 2022

Source: https://www.globalkeysolutions.net/records/483/remedyrepack-inc/7643db5a-88a8-42c0-81f4-05464ba24b16

> FDA 483 for RemedyRepack Inc. on November 10, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RemedyRepack Inc.
- Inspection Date: 2022-11-10
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: RemedyRepack Inc. in Indiana, PA, a repackager/relabeler, was inspected by the FDA and received a Form 483 with six observations. The inspection revealed significant deficiencies in written procedures, including a lack of process validation, equipment qualification, cleaning validation, change control, and procedures for packaging component handling. Additionally, the firm failed to adequately investigate discrepancies and did not retain reserve samples for the required duration.

## Related Documents

- [483 - 2025-04-14](https://www.globalkeysolutions.net/records/483/remedyrepack-inc/4bbf7849-d81d-4d6b-8179-f9b9ba3293dc)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)

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

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