# FDA 483 - IPR Pharmaceuticals, Inc. - June 14, 2018

Source: https://www.globalkeysolutions.net/records/483/ipr-pharmaceuticals-inc/6167fbc9-2e2d-4eb3-9d94-b1d46f975693

> FDA 483 for IPR Pharmaceuticals, Inc. on June 14, 2018. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: IPR Pharmaceuticals, Inc.
- Inspection Date: 2018-06-14
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA inspection of IPR Pharmaceuticals, Inc. in Canovanas, PR, revealed a significant deficiency in control procedures for manufacturing processes. The firm failed to establish adequate controls for processes that could cause variability in in-process material and drug product characteristics. This was evidenced by temperature and humidity excursions affecting Crestor 10mg core tablets, leading to out-of-trend results for assay and degradation products, without sufficient stability data or monitoring to support product release.

## Related Documents

- [WARNING_LETTER - 2020-08-31](https://www.globalkeysolutions.net/records/warning_letter/ipr-pharmaceuticals-inc/e58d0c86-a64f-401d-9ce2-6051858986cd)
- [CRL - Unknown Date](https://www.globalkeysolutions.net/records/crl/ipr-pharmaceuticals-inc/f3f081b0-7c3c-46f1-b176-7a7d499c5e94)
- [WARNING_LETTER - 2025-06-10](https://www.globalkeysolutions.net/records/warning_letter/ipr-pharmaceuticals-inc/814d6d88-7437-49cf-84db-4ac4a311c955)

## Related Officers

- [Laurimer Kuilan-Torres](https://www.globalkeysolutions.net/people/laurimer-kuilan-torres/a7f49e33-9d35-4dfe-8bcc-d369d3834ef4)

Company: https://www.globalkeysolutions.net/companies/ipr-pharmaceuticals-inc/b4dde979-22da-4c56-93c5-a44a726cff7a

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6