# FDA 483 - Tri-Med, Inc. dba Advanced Care Infusion-Shelby - July 11, 2017

Source: https://www.keypedia.com/records/483/tri-med-inc-dba-advanced-care-infusion-shelby/4e81f5d3-361e-4d97-8197-709a7da43710

> FDA 483 for Tri-Med, Inc. dba Advanced Care Infusion-Shelby on July 11, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tri-Med, Inc. dba Advanced Care Infusion-Shelby
- Inspection Date: 2017-07-11
- Product Type: Drugs
- Office Name: Detroit District Office
- Summary: During an FDA inspection on July 11, 2017, the firm was cited for four observations related to aseptic processing and environmental controls, all of which were repeat observations from a previous FDA 483 issued on February 23, 2015.

Observation 1 noted that disinfecting agents and cleaning wipes used in aseptic processing areas were not sterile. Specifically, non-sterile disinfectant and wipes were used to sanitize Lioresal 2000MCG/ML (2X20ML) SYRINGE ampules and a box prior to transfer into the ISO 5 hood, with no additional sanitization. These non-sterile wipes were also used within the ISO 5 hood.

Observation 2 detailed inadequate aseptic techniques by personnel during the processing of Lioresal 2000MCG/ML (2X20ML) SYRINGE. Issues included a technician wearing non-sterile gloves during ISO 5 hood sanitization, returning to the ISO 5 hood without sanitizing gloves after retrieving materials, donning sterile gloves non-aseptically over non-sterile gloves, non-sterile gown sleeves contacting the ISO 5 hood surface, and non-deliberate hand movements within the ISO 5 hood.

Observation 3 stated that equipment, materials, and supplies were not disinfected prior to entering aseptic processing areas. Components were wiped with non-sterile disinfectant by a technician wearing non-sterile gloves and then

## Related Documents

- [483 - 2015-02-23](https://www.keypedia.com/records/483/tri-med-inc-dba-advanced-care-infusion-shelby/04ae4cdf-6918-446d-8206-4717f57e13d0)
- [483 - 2015-02-23](https://www.keypedia.com/records/483/tri-med-inc-dba-advanced-care-infusion-shelby/5dccdfe4-d0c9-4a94-9329-8bff22bacceb)
- [WARNING_LETTER - 2015-02-23](https://www.keypedia.com/records/warning_letter/tri-med-inc-dba-advanced-care-infusion-shelby/0c9fc5ae-62fb-4a00-8546-796a8127fc68)
- [STATE_REFERRAL_LETTER - 2017-06-26](https://www.keypedia.com/records/state_referral_letter/tri-med-inc-dba-advanced-care-infusion-shelby/90abe4e7-fa98-47e4-9ca5-a457272d566a)

## Related Officers

- [Emily J. Orban](https://www.keypedia.com/people/emily-j-orban/e0008df4-4986-413d-a943-9fafcf385021)
- [Bei Y. Ho](https://www.keypedia.com/people/bei-y-ho/fe0bd521-2b0b-4760-b955-ad25dd3e2f91)

Company: https://www.keypedia.com/companies/tri-med-inc-dba-advanced-care-infusion-shelby/0678e8c0-b6c7-42ce-8f77-e4227559803b

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03