# FDA 483 - OurPharma LLC - September 30, 2021

Source: https://www.keypedia.com/records/483/ourpharma-llc/c0c59347-7f46-4697-8f67-732836287495

> FDA 483 for OurPharma LLC on September 30, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OurPharma LLC
- Inspection Date: 2021-09-30
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: This FDA Form 483 document outlines deficiencies observed during an inspection of an unnamed facility's aseptic processing areas.

**Environmental Monitoring Deficiencies:**
*   The firm lacks documented justification for the orientation of non-viable particle monitoring probes within the ISO 5 biological safety cabinets (BSCs).
*   The isokinetic probe's placement is not fixed and is subject to movement during BSC cleaning, preventing demonstration of meaningful sample collection.
*   The non-viable particulate probes and active air samplers within the ISO 5 BSCs have not been qualified under actual conditions of use. The initial system qualification occurred in (b)(4), while the BSCs were installed in January/February 2019.

**Cleaning and Disinfection Deficiencies:**
*   The material used for the armrests on the ISO 5 BSCs was not included in the disinfectant efficacy study, meaning there is no documentation to show disinfectant effectiveness on this specific material.
*   The firm has not evaluated the suitability of the armrest material for use in an ISO 5/ISO 7 cleanroom environment or for sterile production.

## Related Officers

- [Margaret M. Annes](https://www.keypedia.com/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

Company: https://www.keypedia.com/companies/ourpharma-llc/dbbce00b-ea04-4406-a289-aaccab319b5b

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9