# FDA 483 - Llorens Pharmaceuticals International Division, Inc. - March 11, 2020

Source: https://www.globalkeysolutions.net/records/483/llorens-pharmaceuticals-international-division-inc/5eb43b92-e4b3-441c-af11-323b7326b4a9

> FDA 483 for Llorens Pharmaceuticals International Division, Inc. on March 11, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Llorens Pharmaceuticals International Division, Inc.
- Inspection Date: 2020-03-11
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Llorens Pharmaceuticals International Division, Inc. in Miami, FL, was cited for significant deficiencies in its quality control unit, laboratory facilities, and record-keeping practices during an FDA inspection. The firm failed to establish and follow written procedures for critical analytical processes like HPLC chromatogram evaluation and stability testing, and did not adequately investigate out-of-specification results. Additionally, unsanitary laboratory glassware and incomplete batch production records for in-process controls were observed, indicating a lack of robust quality systems for manufacturing OTC drugs and dietary supplements.

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## Related Officers

- [Special Assistant](https://www.globalkeysolutions.net/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)

Company: https://www.globalkeysolutions.net/companies/llorens-pharmaceuticals-international-division-inc/3bc4594c-275f-4451-9cf8-4e2e9bc14ee4

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