# FDA 483 - Unipharma, Llc. - May 07, 2019

Source: https://www.keypedia.com/records/483/unipharma-llc/8dabe54e-6045-4580-8149-147352f8710c

> FDA 483 for Unipharma, Llc. on May 07, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Unipharma, Llc.
- Inspection Date: 2019-05-07
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: The FDA inspection of Unipharma, Llc. in Tamarac, FL, revealed significant deficiencies across its quality, production, and laboratory systems, particularly impacting over-the-counter drug products for infants and pediatric patients. Key issues included inadequate investigations into microbial contamination in purified water, release of drug products without proper Quality Assurance approval, and a lack of robust process validation and stability data to support product shelf-life. These findings indicate a serious lack of control over critical manufacturing processes and product quality, posing potential risks to public health.

## Related Officers

- [investigator](https://www.keypedia.com/people/rozelle-g-smith/cd2488c0-fe18-4fc4-a80e-20d08a8d12cc)

Company: https://www.keypedia.com/companies/unipharma-llc/dfe82b4a-d07e-435b-8ffb-e4f071d5fc80

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6