# FDA 483 - NEOLPHARMA, INC. - April 01, 2022

Source: https://www.globalkeysolutions.net/records/483/neolpharma-inc/b70c1b89-4a7b-43c6-a543-7349cb4fcd1b

> FDA 483 for NEOLPHARMA, INC. on April 01, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NEOLPHARMA, INC.
- Inspection Date: 2022-04-01
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: NEOLPHARMA, INC. in Caguas, PR, was inspected by the FDA, revealing significant deficiencies in its quality system. The firm failed to follow its own written production and process control procedures, including issues with deviation reporting, change control, work order management, and good documentation practices. Additionally, several standard operating procedures were found to be deficient, lacking specificity and clear instructions for critical operations and facility management.

## Related Documents

- [483 - 2017-06-07](https://www.globalkeysolutions.net/records/483/neolpharma-inc/80304280-74a5-4b9a-84fa-b65f4da9cc2a)
- [483 - 2019-02-05](https://www.globalkeysolutions.net/records/483/neolpharma-inc/53ad6b49-3c5d-4699-9378-880fdb8b764e)

## Related Officers

- [Angelica M. Hernandez](https://www.globalkeysolutions.net/people/angelica-m-hernandez/d66d920c-01b6-4770-a1b5-cac9a1790a0e)
- [Alan A. Rivera](https://www.globalkeysolutions.net/people/alan-a-rivera/4bec02c3-c62e-4b3a-a6ab-02c3386549bf)
- [investigator](https://www.globalkeysolutions.net/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)

Company: https://www.globalkeysolutions.net/companies/neolpharma-inc/4a216d1c-7206-434a-82df-ca1a8f1fe43b

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