# FDA 483 - PLD Acquisitions LLC - September 21, 2021

Source: https://www.globalkeysolutions.net/records/483/pld-acquisitions-llc/697a3c77-edef-462e-84da-d9a6175cbdbd

> FDA 483 for PLD Acquisitions LLC on September 21, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PLD Acquisitions LLC
- Inspection Date: 2021-09-21
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: PLD Acquisitions LLC D/B/A Avema Pharma Solutions, a prescription and OTC drug manufacturer in Doral, FL, was cited for multiple significant deficiencies during an FDA inspection. Key issues include inadequate water system controls, widespread data integrity problems in laboratory records, failure to follow established test procedures, and insufficient equipment cleaning and process control documentation. Several observations, including equipment cleaning and investigation failures, were repeat findings from a previous inspection.

## Related Documents

- [483 - 2025-02-28](https://www.globalkeysolutions.net/records/483/pld-acquisitions-llc/b8e8850b-2b73-4286-9463-5d472e78d230)

## Related Officers

- [Teresa I. Navas](https://www.globalkeysolutions.net/people/teresa-i-navas/43f747c0-18c2-4630-bab9-936204aa93aa)
- [Jennifer Lalama](https://www.globalkeysolutions.net/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)

Company: https://www.globalkeysolutions.net/companies/pld-acquisitions-llc/cafd527d-29ba-4b4c-9ac9-cfa1cdedfc6a

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