# FDA 483 - AVEVA Drug Delivery Systems, Inc. - July 26, 2019

Source: https://www.globalkeysolutions.net/records/483/aveva-drug-delivery-systems-inc/a5d313a9-e652-474f-b6cb-e57f2260ecea

> FDA 483 for AVEVA Drug Delivery Systems, Inc. on July 26, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AVEVA Drug Delivery Systems, Inc.
- Inspection Date: 2019-07-26
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of AVEVA Drug Delivery Systems, Inc. in Miramar, FL, a manufacturer of transdermal patches and sublingual films, revealed significant issues with quality control. The firm failed to thoroughly review unexplained discrepancies and ensure batches met specifications, as evidenced by undetected manufacturing defects and inadequate investigations. Additionally, the company's appearance specifications for drug products were found to be deficient, lacking clear criteria for handling defective units.

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## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/haley-h-seymour/721a8937-0b2d-418c-bc8f-daa827ae6b92)
- [Dhrvi Kalra](https://www.globalkeysolutions.net/people/dhrvi-kalra/b9f07d03-5a38-42c6-aa9d-016ba0f84147)
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- [Jennifer Lalama](https://www.globalkeysolutions.net/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)

Company: https://www.globalkeysolutions.net/companies/aveva-drug-delivery-systems-inc/54790ed2-6912-4f90-8120-2e933adcfa47

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