# FDA 483 - Rx Unlimited Pharmacy - October 21, 2022

Source: https://www.keypedia.com/records/483/rx-unlimited-pharmacy/d6ba78f3-e514-4d7d-86f9-b9e4c0057330

> FDA 483 for Rx Unlimited Pharmacy on October 21, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rx Unlimited Pharmacy
- Inspection Date: 2022-10-21
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Rx Unlimited Pharmacy in North Hills, CA, a producer of nonsterile and sterile drug products, revealed significant deficiencies. Observations included inadequate cleaning to prevent cross-contamination of hazardous drugs, use of non-pharmaceutical grade components without proper testing, improper gowning procedures, and pest activity in production-adjacent areas. These issues indicate a lack of control over manufacturing processes and environmental conditions, posing potential risks to drug product quality and patient safety.

## Related Documents

- [483 - 2022-10-21](https://www.keypedia.com/records/483/rx-unlimited-pharmacy/d8c69541-6046-4066-adde-360fd9c75ed3)
- [UNTITLED_LETTER - 2022-10-21](https://www.keypedia.com/records/untitled_letter/rx-unlimited-pharmacy/24b3c562-b152-4a84-b0eb-e9b438dfd22d)

## Related Officers

- [Investigator](https://www.keypedia.com/people/jolanna-a-norton/5501fea4-4bfd-434c-b2aa-fcf94444f684)
- [Stryker, Regulatory Affairs](https://www.keypedia.com/people/gunneet-kaur/e2823ed9-44f2-4553-8984-895ef8c7eece)

Company: https://www.keypedia.com/companies/rx-unlimited-pharmacy/2dd716b6-69d5-4629-9fe8-43957344f923

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6