# FDA 483 - Pharmalogic Puerto Rico Inc - December 27, 2013

Source: https://www.keypedia.com/records/483/pharmalogic-puerto-rico-inc/23afd5f9-50ef-48b2-8678-adeb042244c3

> FDA 483 for Pharmalogic Puerto Rico Inc on December 27, 2013. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmalogic Puerto Rico Inc
- Inspection Date: 2013-12-27
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA inspection of Lantheus MI Radiopharmaceuticals Inc. in San Juan, PR, a PET Manufacturer, revealed significant deficiencies in quality control and aseptic processing. The firm failed to conduct investigations into environmental excursions, lacked adequate procedures for incoming material control, and exhibited poor production and process controls, including issues with operator qualification and aseptic technique. Additionally, quality assurance procedures for reviewing cleaning records were not consistently followed.

## Related Documents

- [EIR - 2016-07-22](https://www.keypedia.com/records/eir/pharmalogic-puerto-rico-inc/a4760a86-149e-49e4-a0bf-58bddb95c833)
- [483 - 2016-07-22](https://www.keypedia.com/records/483/pharmalogic-puerto-rico-inc/8007b96c-1095-4562-b32a-feef19e58ae5)

## Related Officers

- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)

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

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