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

Source: https://www.keypedia.com/records/483/accurate-rx-pharmacy-consulting-llc/48741a39-529e-465f-a994-2410c4ec410a

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

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## 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: An FDA inspection of Accurate Rx Pharmacy Consulting, LLC dba Diplomat Specialty Infusion Group, a sterile human drug producer in Columbia, MO, identified critical deficiencies in aseptic processing. Observations included the use of non-sterile cleaning agents and wipes in ISO 5 areas, the presence of difficult-to-clean equipment surfaces, and a failure to disinfect materials before their transfer into aseptic processing environments. These findings indicate a lack of adequate controls to prevent contamination during sterile drug production.

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- [483 - 2021-07-15](https://www.keypedia.com/records/483/accurate-rx-pharmacy-consulting-llc/ee1a423f-39b4-4fa9-826f-00ec24ec2c8f)
- [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)

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
