# FDA 483 - People's Custom Rx and Clinical Care, LLC - July 29, 2015

Source: https://www.keypedia.com/records/483/peoples-custom-rx-and-clinical-care-llc/0ba0d7b1-8f5b-416d-8de2-7373c3a9c2e4

> FDA 483 for People's Custom Rx and Clinical Care, LLC on July 29, 2015. 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: 2015-07-29
- Product Type: Drugs
- Summary: From July 20-29, 2015, the FDA inspected People's Custom Rx and Clinical Care, LLC, a producer of sterile drug products in Memphis, TN. The inspection revealed nine observations regarding the firm's manufacturing practices and quality systems.

Observation 1 noted inadequate procedures to prevent microbiological contamination. A technician re-entered a clean room without changing garbing, non-sterile 99% Isopropyl Alcohol was used for sanitization, and non-sterile, reused gowning components were permitted.

Observation 2 cited deficiencies in environmental monitoring. Weekly air and surface monitoring was deemed inadequate, with insufficient sample points and infrequent monitoring of technicians' fingertips.

Observation 3 detailed issues with material flow, specifically the lack of decontamination for supplies and components before introduction into aseptic processing areas.

Observation 4 highlighted deficiencies in maintaining equipment for aseptic conditions. Smoke studies for ISO 5 hoods were not video recorded, documented, or performed under dynamic conditions, and pressure in controlled areas was only checked once daily.

Observation 5 identified a lack of validation for sterilization processes, including stock solutions, autoclaving rubber stoppers and finished drug products, depyrogenating/sterilizing glassware, and terminal sterilization of oil-based drug products.

Observation 6 reported issues with equipment calibration. A Boekel incubator for sterility samples was consistently out of range (25.2°C to 30.8°C vs. 22

## Related Documents

- [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 - 2019-07-24](https://www.keypedia.com/records/483/peoples-custom-rx-and-clinical-care-llc/0e3961b3-d031-4056-86da-a759a1bc4e92)
- [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

- [Supervisory Investigator at FDA](https://www.keypedia.com/people/zada-l-giles/29930e94-66c8-4d36-9220-b2ecbfe12351)
- [Mary A. Millner](https://www.keypedia.com/people/mary-a-millner/bd8911cf-849d-41d2-ae12-dd4bad66e798)

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