# FDA 483 - NEOLPHARMA, INC. - February 05, 2019

Source: https://www.globalkeysolutions.net/records/483/neolpharma-inc/53ad6b49-3c5d-4699-9378-880fdb8b764e

> FDA 483 for NEOLPHARMA, INC. on February 05, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NEOLPHARMA, INC.
- Inspection Date: 2019-02-05
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Neopharma, Inc. in Caguas, PR, was inspected from January 24 to February 5, 2019, revealing a significant issue with procedures to prevent objectionable microorganisms in non-sterile drug products. The firm has experienced recurring microbiological deviations, even after implementing corrective and preventive actions stemming from a previous inspection. This indicates a persistent problem with microbial control within their manufacturing area.

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## Related Officers

- [Retired](https://www.globalkeysolutions.net/people/ariel-cruz-figueroa/c6ade050-dbe1-4aa3-b88f-980db51b88b0)

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