# FDA 483 - Techni Med, Inc. dba The Compounder - January 26, 2018

Source: https://www.keypedia.com/records/483/techni-med-inc-dba-the-compounder/62947302-0b5a-4f90-8983-c1e6a44593c6

> FDA 483 for Techni Med, Inc. dba The Compounder on January 26, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Techni Med, Inc. dba The Compounder
- Inspection Date: 2018-01-26
- Product Type: Drugs
- Office Name: Chicago District Office
- Summary: From January 8-26, 2018, the FDA inspected Techni Med, Inc. dba The Compounder, a producer of sterile and non-sterile drug products in Aurora, IL. The inspection revealed multiple violations related to sterile drug production, quality control, and documentation.

**Key Observations:**

*   **Sterile Product Contamination Prevention (Observation 1):**
    *   Personnel gloved bare hands inside the ISO-5 area during aseptic processing.
    *   Inadequately protected sterile product was exposed to air quality lower than ISO 5.
    *   ISO 5 areas were not certified under representative dynamic conditions; smoke studies did not reflect actual aseptic processing.
    *   Media fills did not simulate worst-case aseptic production activities.
    *   Environmental monitoring was not performed in all aseptic processing areas (e.g., pass-throughs) and was not conducted during every drug production shift in the ISO-5 area.
    *   Pressure differentials between classified areas were not continuously monitored.
    *   Finished products, including 1 ML 31G 5/16IN TRIMIX SYRINGE and THIAMINE INJECTION 30 ML, were distributed without patient-specific prescriptions and lacked testing for objectionable microorganisms.

*   **Product Testing and Release (Observation 2):**
    *   Intrathecal products (e.g., Hydromorphine

## Related Documents

- [483 - 2015-07-09](https://www.keypedia.com/records/483/techni-med-inc-dba-the-compounder/cb3e6fda-5e1b-4f12-a7f2-49b94a27904c)
- [483 - 2019-10-10](https://www.keypedia.com/records/483/techni-med-inc-dba-the-compounder/79e04624-7df0-4674-95cc-20c04075661a)
- [483 - 2019-10-10](https://www.keypedia.com/records/483/techni-med-inc-dba-the-compounder/ae25448a-c2fe-452b-99be-a14d8775cd8c)
- [STATE_REFERRAL_LETTER - 2019-09-23](https://www.keypedia.com/records/state_referral_letter/techni-med-inc-dba-the-compounder/2fad97f6-7b03-49b9-a027-4dfd80805ff8)

## Related Officers

- [Bryan L. Mcguckin](https://www.keypedia.com/people/bryan-l-mcguckin/33eaa16d-a642-4945-81f3-5d9ac180c2db)
- [Regulatory Counsel, CDER Compliance, Office of Manufacturing Quality](https://www.keypedia.com/people/emilie-e-kahn/fac179e5-478f-4e75-9632-40d921f44a8f)

Company: https://www.keypedia.com/companies/techni-med-inc-dba-the-compounder/26a326d7-a5ba-476e-b77f-1fbf12be6a7d

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669