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

Source: https://www.keypedia.com/records/483/infusion-systems-of-sw-florida-inc-dba-myerlee-pharmacy/c688553c-0268-4608-a2d8-61f1ccb43cb8

> 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: Florida District Office
- Summary: An FDA inspection conducted from August 2 to August 11, 2022, at Infusion Systems of SW Florida Inc. (dba Myerlee Pharmacy) identified significant manufacturing deficiencies. The company, a producer of sterile and non-sterile products, received a Form FDA 483 citing two main observations. First, the inspection revealed inadequate product evaluation and failure to take remedial action following the detection of an objectionable microbial contaminant, Rhizopus, in the ISO 8 prep room's viable air sample on May 17, 2022. This area is adjacent to the ISO 5 aseptic processing zone. Despite this finding, Myerlee Pharmacy continued compounding sterile products such as Morphine Sulfate and Vancomycin solutions, indicating a lapse in environmental control and product safety. Second, the FDA observed that the sterilization process intended for final products, particularly intrathecal preparations, was not adequate to ensure sterility. A specific component used in contact with the product during the sterilization process lacked appropriate validation or testing, raising concerns about the efficacy of the entire sterilization procedure. These observations, reported under Section 704(b) of the Federal Food, Drug and Cosmetic Act, suggest that products may have been prepared or held under conditions that could render them contaminated or injurious to health. The pharmacy is expected to address these critical issues to ensure the safety and quality of its compounded medications.

## Related Documents

- [483 - 2017-07-20](https://www.keypedia.com/records/483/infusion-systems-of-sw-florida-inc-dba-myerlee-pharmacy/f2932c03-8815-4ff7-9f77-2ba49f0c2b57)
- [483 - 2019-12-17](https://www.keypedia.com/records/483/infusion-systems-of-sw-florida-inc-dba-myerlee-pharmacy/f6b0a074-2fbb-43bf-8d45-cf8bf87fd14e)
- [483 - 2022-08-11](https://www.keypedia.com/records/483/infusion-systems-of-sw-florida-inc-dba-myerlee-pharmacy/a2cf75e9-5de0-4f71-8e45-2985609af173)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9