# FDA 483 - Accurate RX Pharmacy Consulting LLC - July 15, 2021

Source: https://www.keypedia.com/records/483/accurate-rx-pharmacy-consulting-llc/ee1a423f-39b4-4fa9-826f-00ec24ec2c8f

> FDA 483 for Accurate RX Pharmacy Consulting LLC on July 15, 2021. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Accurate RX Pharmacy Consulting LLC
- Inspection Date: 2021-07-15
- Product Type: Drugs
- Office Name: Kansas City District Office
- Summary: During inspections conducted on July 6-8 and July 15, 2021, the Food and Drug Administration (FDA) issued a Form 483 to Accurate Rx Pharmacy Consulting, LLC, operating as Diplomat Specialty Infusion Group, a sterile human drug producer in Columbia, MO. The document outlined significant observations regarding the firm's sterile processing practices.

The FDA investigators observed three primary areas of concern. First, non-sterile disinfecting agents, wipes, and pads were being used within the critical ISO 5 classified aseptic processing areas. This compromises the sterile environment necessary for drug production. Second, these aseptic processing areas contained equipment and surfaces that were difficult to adequately clean, specifically an uncleaned porthole on a laminar air flow hood and uncleaned outer packaging of wipes. This indicates inadequate cleaning procedures and potential for microbial harborage. Finally, the firm failed to disinfect materials, such as a sterile bottle, before transferring them from an ISO 7 room into the more critical ISO 5 laminar air flow hood, introducing a risk of contamination.

These observations, issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, indicate conditions or practices that may lead to drug contamination or render products injurious to health. While not a final determination of non-compliance, the FDA 483 requires the company to address these issues and propose appropriate corrective actions to ensure the sterility and safety of their drug products.

## Related Documents

- [483 - 2017-08-14](https://www.keypedia.com/records/483/accurate-rx-pharmacy-consulting-llc/519dd78b-cbdd-4ded-b770-6b8a2614c479)
- [483 - 2018-09-19](https://www.keypedia.com/records/483/accurate-rx-pharmacy-consulting-llc/d8cf8d4d-f9aa-4723-a1fc-8068fcbf0443)
- [WARNING_LETTER - 2018-09-19](https://www.keypedia.com/records/warning_letter/accurate-rx-pharmacy-consulting-llc/224c7505-fe6a-4f5c-a901-817aa8bec6f3)
- [483 - 2021-07-15](https://www.keypedia.com/records/483/accurate-rx-pharmacy-consulting-llc/48741a39-529e-465f-a994-2410c4ec410a)
- [STATE_REFERRAL_LETTER - 2021-07-06](https://www.keypedia.com/records/state_referral_letter/accurate-rx-pharmacy-consulting-llc/ac764b0b-bd1c-4a41-b14a-0a4e84644341)

## Related Officers

- [Regulatory Officer ](https://www.keypedia.com/people/jill-tillman/4fd81eed-0de2-468b-a776-d4809fa91553)
- [Investigator?](https://www.keypedia.com/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)
- [Jill Tillman, Regulatory Officer](https://www.keypedia.com/people/jill-tillman-regulatory-officer/f7fc1432-92bd-4c95-b903-137e7090ec84)

Company: https://www.keypedia.com/companies/accurate-rx-pharmacy-consulting-llc/a22d573d-e6cd-495c-98d5-776db9dc2a66

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