# FDA 483 - Foundation Care LLC - March 19, 2013

Source: https://www.keypedia.com/records/483/foundation-care-llc/31e73e24-b936-4013-b7d1-f531061c9a47

> FDA 483 for Foundation Care LLC on March 19, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Foundation Care LLC
- Inspection Date: 2013-03-19
- Product Type: Drugs
- Office Name: Kansas City District Office
- Summary: The FDA Form 483 details numerous deficiencies at a sterile drug product manufacturing facility. Key issues include inadequate procedures to prevent microbiological contamination. The media fill procedure and documentation are insufficient, lacking details on processing times, intervention types/numbers, and maximum personnel in the ISO 5 cleanroom during dynamic operations.

Environmental monitoring is deficient; SOP 8B.16 fails to include daily dynamic monitoring for the ISO 5 cleanroom and omits equipment like BAXA pumps and chairs from monthly monitoring. Daily personnel monitoring is not performed, with annual monitoring only. A smoke study procedure for the ISO 5 cleanroom under dynamic conditions is absent, and no studies have been conducted since 2005, or after a 2007 air handling unit installation.

Aseptic cleaning practices are not consistently followed (e.g., overlapping strokes, top-to-bottom). Glove change frequency is undefined, and employees were observed not changing gloves after contamination. Aseptic technique breaches include leaving the cleanroom/anteroom door open and employees failing to follow handwashing procedures (e.g., rinsing from fingertips to elbows). The anteroom lacks a clock for handwashing timing. Exposed skin around the neck and face was observed due to inadequate gowning (non-sterile surgical gowns, home-laundered scrubs, non-sterile bouffant caps, masks, shoe covers).

Product testing is insufficient; potency testing is not routine (e.g.,

## Related Documents

- [483_RESPONSE - 2013-03-19](https://www.keypedia.com/records/483_response/foundation-care-llc/2d927465-899a-43cf-8551-fa043de68316)

## Related Officers

- [Owner](https://www.keypedia.com/people/shirley-j-berryman/44c8edab-2053-4af0-84fe-146b8168cd10)
- [Investigator](https://www.keypedia.com/people/anthony-r-bucks/e6d615b8-86bc-4bc6-af46-ed973bf57efb)

Company: https://www.keypedia.com/companies/foundation-care-llc/4684e7ad-74ad-4131-9ac9-8a66293e7c52

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79