# FDA 483 - Apollo Care, LLC - April 05, 2023

Source: https://www.keypedia.com/records/483/apollo-care-llc/0ac56145-ec39-46b5-be91-7e2a9a275bbc

> FDA 483 for Apollo Care, LLC on April 05, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Apollo Care, LLC
- Inspection Date: 2023-04-05
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Apollo Care, LLC, an outsourcing facility in Columbia, MO, was inspected and cited for significant deficiencies in quality control, aseptic processing, and labeling. Observations included failures to investigate discrepancies, inadequate aseptic process validation, non-adherence to contamination prevention procedures, improper drug product storage, and missing required information on drug product labels and containers. This inspection also noted a repeat observation from 2018 regarding discrepancy review.

## Related Documents

- [483 - 2018-03-13](https://www.keypedia.com/records/483/apollo-care-llc/c52716c7-930d-437d-8345-9d00480ebb74)
- [483 - 2021-09-08](https://www.keypedia.com/records/483/apollo-care-llc/fcb156eb-b4e9-4b9c-9782-6713ff38b2f2)
- [483 - 2023-04-05](https://www.keypedia.com/records/483/apollo-care-llc/49963de2-b507-405d-981f-2e335fe5906e)
- [483 - 2025-03-27](https://www.keypedia.com/records/483/apollo-care-llc/aff9bc2a-a013-4a98-bc53-06f938821c88)
- [WARNING_LETTER - 2025-03-27](https://www.keypedia.com/records/warning_letter/apollo-care-llc/1259d49f-a767-4776-9135-2cf094b21ccd)

## Related Officers

- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)
- [Consumer Safety Officer, FDA](https://www.keypedia.com/people/conner-n-mann/626fec03-b389-435c-b038-376fcc0952ac)
- [CDR Carl A. Huffman III](https://www.keypedia.com/people/cdr-carl-a-huffman-iii/c795e3ce-de9a-4567-9bdb-99ba9ac4731a)

Company: https://www.keypedia.com/companies/apollo-care-llc/469ed487-7a02-4eb8-beb4-474f95d475f9

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8