# FDA 483 - Techni Med, Inc. dba The Compounder - October 10, 2019

Source: https://www.keypedia.com/records/483/techni-med-inc-dba-the-compounder/79e04624-7df0-4674-95cc-20c04075661a

> FDA 483 for Techni Med, Inc. dba The Compounder on October 10, 2019. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Techni Med, Inc. dba The Compounder
- Inspection Date: 2019-10-10
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: An FDA Form 483 was issued following an inspection that identified two observations related to contamination control and environmental monitoring.

Observation 1 details non-microbial contamination in the production area. On September 23, 2019, black residue was observed on two white plastic garbage cans, one located in the ISO 7 cleanroom and another in the ISO 8 anteroom. Additionally, black residue was noted on the far corner of the ISO 7 cleanroom floor.

Observation 2 addresses inadequate product evaluation and remedial action concerning actionable microbial contamination adjacent to the ISO 5 aseptic processing area during production. On May 23, 2018, a cleanroom certification revealed out-of-specification results for viable monitoring in one ISO 8 location and four ISO 7 locations. Despite routine cleaning and environmental monitoring resuming, a follow-up cleanroom certification was not conducted until September 12, 2018. Sterile processing continued routinely between May 23, 2018, and September 12, 2018.

## Related Documents

- [483 - 2015-07-09](https://www.keypedia.com/records/483/techni-med-inc-dba-the-compounder/cb3e6fda-5e1b-4f12-a7f2-49b94a27904c)
- [483 - 2018-01-26](https://www.keypedia.com/records/483/techni-med-inc-dba-the-compounder/62947302-0b5a-4f90-8983-c1e6a44593c6)
- [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

- [Deputy Commissioner for Foods](https://www.keypedia.com/people/james-k-ireland/78658286-3e62-4069-a8e1-b157aa77c7fe)

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

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7