# FDA 483 - ChiRhoClin, Inc - September 15, 2025

Source: https://www.keypedia.com/records/483/chirhoclin-inc/4cbbc786-1379-41d5-8608-38bccfa5debd

> FDA 483 for ChiRhoClin, Inc on September 15, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ChiRhoClin, Inc
- Inspection Date: 2025-09-15
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: ChiRhoClin, Inc. in Burtonsville, MD, was inspected by the FDA and received a Form 483 with eight observations. The inspection revealed significant deficiencies in quality control, including inadequate stability testing programs, deficient laboratory records, and a lack of proper change control procedures. These issues indicate a systemic failure to maintain robust quality management systems for drug product manufacturing and testing.

## Related Documents

- [483 - 2022-11-03](https://www.keypedia.com/records/483/chirhoclin-inc/00aec741-5a69-44c1-b3e9-9564751fe7b5)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/catherine-o-lamptey/9ddfa564-70b7-4a8b-9209-9d21205ebf60)
- [Investigator](https://www.keypedia.com/people/pushpa-s-jayasekara/cfd7d22f-b4c2-4002-ae18-b5435815d27d)
- [Claude Noel Y. Zanetsie](https://www.keypedia.com/people/claude-noel-y-zanetsie/d2341300-2c9d-4d22-bb70-5b442d4e3b70)

Company: https://www.keypedia.com/companies/chirhoclin-inc/a63ad8fd-139c-40ea-bc63-d690e9b58437

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