# FDA 483 - Pharmalogic Puerto Rico Inc - July 22, 2016

Source: https://www.globalkeysolutions.net/records/483/pharmalogic-puerto-rico-inc/8007b96c-1095-4562-b32a-feef19e58ae5

> FDA 483 for Pharmalogic Puerto Rico Inc on July 22, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmalogic Puerto Rico Inc
- Inspection Date: 2016-07-22
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA inspection of Lantheus MI Radipharmaceuticals Inc. in San Juan, PR, revealed a significant issue regarding the conditional release of PET drug products. The firm approved batches despite analytical equipment malfunctions without documenting efforts to prevent recurrence. This indicates a lapse in quality control and documentation practices.

## Related Documents

- [483 - 2013-12-27](https://www.globalkeysolutions.net/records/483/pharmalogic-puerto-rico-inc/23afd5f9-50ef-48b2-8678-adeb042244c3)
- [EIR - 2016-07-22](https://www.globalkeysolutions.net/records/eir/pharmalogic-puerto-rico-inc/a4760a86-149e-49e4-a0bf-58bddb95c833)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/pharmalogic-puerto-rico-inc/d8cf4e25-cba0-40d3-a655-b6360745a830

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