# FDA 483 - NEOLPHARMA, INC. - June 07, 2017

Source: https://www.globalkeysolutions.net/records/483/neolpharma-inc/80304280-74a5-4b9a-84fa-b65f4da9cc2a

> FDA 483 for NEOLPHARMA, INC. on June 07, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NEOLPHARMA, INC.
- Inspection Date: 2017-06-07
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Neolpharma, Inc. in Caguas, PR, a drug manufacturer, was cited for significant deficiencies during an FDA inspection. The firm failed to implement adequate controls to prevent objectionable microorganisms in manufacturing areas, with multiple instances of fungal and bacterial contamination. Additionally, the inspection revealed inadequate laboratory controls, including a lack of documented procedures for chromatographic data and insecure electronic data acquisition systems, raising concerns about data integrity.

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## Related Officers

- [Rebeca Melendez](https://www.globalkeysolutions.net/people/rebeca-melendez/acc4240d-9b2d-4601-a836-3edf750c3849)
- [Libia Lugo](https://www.globalkeysolutions.net/people/libia-lugo/55f1387e-b6bd-41ca-8507-45829629dac5)

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