# FDA 483 - People's Custom Rx and Clinical Care, LLC - July 24, 2019

Source: https://www.keypedia.com/records/483/peoples-custom-rx-and-clinical-care-llc/0e3961b3-d031-4056-86da-a759a1bc4e92

> FDA 483 for People's Custom Rx and Clinical Care, LLC on July 24, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: People's Custom Rx and Clinical Care, LLC
- Inspection Date: 2019-07-24
- Product Type: Drugs
- Office Name: New Orleans District Office
- Summary: This FDA Form 483 document outlines observations made during an inspection, indicating several deficiencies in the facility's aseptic processing and cleaning procedures.

**Facility and Operation Details:** The inspection observed the aseptic processing of "Tri-Mix, lot #07162019@34." The facility includes ISO 5 classified aseptic processing areas and cleanrooms with HEPA filters.

**Violations and Observations:**
1.  **Glove Disinfection:** On July 16, 2019, an operator processing Tri-Mix (lot #07162019@34) placed gloved hands outside the ISO 5 area and did not consistently re-sanitize them before returning them under the ISO 5 hood. This indicates a failure to disinfect gloves to prevent contamination.
2.  **Non-Sterile Cleaning Wipes:** On July 16, 2019, an operator used a non-sterile wipe to apply sterile (b)(4) to the exterior of the HEPA filter inside the ISO 5 hood in the cleanroom. This suggests the use of non-sterile materials in critical aseptic areas.
3.  **Smoke Studies:** A review of the cleanroom certification report dated March 28, 2019, revealed that smoke studies in the ISO 5 hood were not performed under dynamic conditions. This indicates an inadequate assessment of airflow patterns and potential contamination risks

## Related Documents

- [483 - 2015-07-29](https://www.keypedia.com/records/483/peoples-custom-rx-and-clinical-care-llc/0ba0d7b1-8f5b-416d-8de2-7373c3a9c2e4)
- [483_RESPONSE - 2015-07-29](https://www.keypedia.com/records/483_response/peoples-custom-rx-and-clinical-care-llc/3376f76d-1874-4d02-adef-17cf85085967)
- [483 - 2018-07-02](https://www.keypedia.com/records/483/peoples-custom-rx-and-clinical-care-llc/1e9000f3-c065-4470-8a88-b42d18f95ae2)
- [483 - 2018-07-02](https://www.keypedia.com/records/483/peoples-custom-rx-and-clinical-care-llc/2a807a62-1045-4e5a-a6bb-a02364a3530a)
- [483_RESPONSE - 2021-08-05](https://www.keypedia.com/records/483_response/peoples-custom-rx-and-clinical-care-llc/0b64f3bf-1d20-4642-be3d-f873d3137731)

## Related Officers

- [Principal Consultant](https://www.keypedia.com/people/stephen-d-brown/01ff1439-f6d7-4501-a104-573dae30d306)

Company: https://www.keypedia.com/companies/peoples-custom-rx-and-clinical-care-llc/7a7d29e0-b780-4476-9350-9189fd5f8d10

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea