# FDA 483 - Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy - August 11, 2022

Source: https://www.globalkeysolutions.net/records/483/infusion-systems-of-sw-florida-inc-dba-myerlee-pharmacy/a2cf75e9-5de0-4f71-8e45-2985609af173

> FDA 483 for Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy on August 11, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy
- Inspection Date: 2022-08-11
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy in Fort Myers, FL, a producer of sterile and non-sterile products, revealed two significant observations. The firm failed to adequately evaluate products and take remedial action following microbial contamination in a cleanroom area. Additionally, the sterilization process for intrathecal products was found to be inadequate, specifically concerning sterility testing.

## Related Documents

- [483 - 2017-07-20](https://www.globalkeysolutions.net/records/483/infusion-systems-of-sw-florida-inc-dba-myerlee-pharmacy/f2932c03-8815-4ff7-9f77-2ba49f0c2b57)
- [483 - 2019-12-17](https://www.globalkeysolutions.net/records/483/infusion-systems-of-sw-florida-inc-dba-myerlee-pharmacy/f6b0a074-2fbb-43bf-8d45-cf8bf87fd14e)
- [483 - 2022-08-11](https://www.globalkeysolutions.net/records/483/infusion-systems-of-sw-florida-inc-dba-myerlee-pharmacy/c688553c-0268-4608-a2d8-61f1ccb43cb8)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/steven-a-brettler/2a356468-f9da-4b68-a3a1-472567e58e45)
- [Jennifer Lalama](https://www.globalkeysolutions.net/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)

Company: https://www.globalkeysolutions.net/companies/infusion-systems-of-sw-florida-inc-dba-myerlee-pharmacy/ff9ae03d-0225-4261-8f27-86e9d847bda3

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