# FDA 483 - C-Care, LLC - February 27, 2025

Source: https://www.globalkeysolutions.net/records/483/c-care-llc/3cf973c0-290c-4f56-aa66-e15df0296154

> FDA 483 for C-Care, LLC on February 27, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: C-Care, LLC
- Inspection Date: 2025-02-27
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: C-Care, LLC, a drug manufacturer in Linthicum Heights, MD, was cited for significant deficiencies in its quality control system related to raw material management. The firm failed to establish the reliability of component supplier reports of analyses, specifically lacking procedures to qualify suppliers and validate Certificates of Analysis. Additionally, the company did not conduct required strength and purity testing for active pharmaceutical ingredients used in its products.

## Related Documents

- [483 - 2019-09-16](https://www.globalkeysolutions.net/records/483/c-care-llc/6f6a0e44-ef35-4017-aa64-58078bd9cf14)

## Related Officers

- [Yharn Su](https://www.globalkeysolutions.net/people/yharn-su/adf8d810-a416-4394-8f85-4f2c33324c25)
- [Stephenie M. Ortiz](https://www.globalkeysolutions.net/people/stephenie-m-ortiz/b0923b14-b153-4893-8eb2-f5e6b1fd2041)
- [Yaharn Su](https://www.globalkeysolutions.net/people/yaharn-su/75b7f7fd-d853-436e-b538-386a8c6df3cb)
- [Azeezat M. Lawal](https://www.globalkeysolutions.net/people/azeezat-m-lawal/6068345c-a8c8-438e-9b59-f7fc35370a59)

Company: https://www.globalkeysolutions.net/companies/c-care-llc/c3e053b4-6353-40bb-8d40-8c9530bd58dc

Office: https://www.globalkeysolutions.net/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa