# FDA 483 - Techni Med, Inc. dba The Compounder - July 09, 2015

Source: https://www.keypedia.com/records/483/techni-med-inc-dba-the-compounder/cb3e6fda-5e1b-4f12-a7f2-49b94a27904c

> FDA 483 for Techni Med, Inc. dba The Compounder on July 09, 2015. 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: 2015-07-09
- Product Type: Drugs
- Office Name: Chicago District Office
- Summary: This FDA Form 483 details multiple deficiencies observed during an inspection of a facility producing sterile drug products.

**Environmental Control & Aseptic Processing:**
*   The environmental monitoring program is inadequate, lacking viable/non-viable monitoring inside ISO5 laminar flow hoods or adjacent ISO7 clean rooms during aseptic operations.
*   Personnel monitoring (gloves, forearms, chest) is not performed during aseptic processing.
*   No microbiological media test method is established to ensure disinfectant efficacy for microorganism recovery.
*   Personnel were observed wearing non-sterile gowning during aseptic processing in an ISO5 laminar flow hood (e.g., compounding Baclofen 1000mcg/ml Inj. Lot 05072015@588#5).
*   Aseptic processing validation is deficient; media fill studies do not simulate complex conditions, and sterilization processes for products like Progesterone (17-A Hydroxy) Caproate 250mg/ml Inj and Estradiol Valerate in Cottonseed Oil 40mg/ml Inj are not validated.
*   Dynamic smoke studies are not performed in ISO5 laminar flow hoods to ensure proper air patterns.
*   Equipment qualification studies for sterilization equipment are not performed.
*   HEPA filter replacement frequency procedures are not established, and filters in ISO5 laminar flow hoods have not been changed since 2005 and 20

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## Related Officers

- [Senior Compliance Manager](https://www.keypedia.com/people/christina-a-miller/7893b145-2814-4443-a886-29881db45918)

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