# FDA 483 - Catalent Pharma Solutions LLC - May 22, 2026

Source: https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/5e16c0dd-8d4f-4bb5-9e7d-01701e77a4b0

> FDA 483 for Catalent Pharma Solutions LLC on May 22, 2026. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Catalent Pharma Solutions LLC
- Inspection Date: 2026-05-22
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Catalent Pharma Solutions LLC in Morrisville, NC, was inspected from May 18-22, 2026, and cited for deficiencies in their cleaning and maintenance procedures for drug manufacturing equipment. The firm failed to adequately evaluate the effectiveness of disinfectants against recovered environmental microbial isolates and did not follow its own procedures for performing disinfectant efficacy studies. This indicates a significant concern regarding the control of microbial contamination in their drug product manufacturing facility.

## Related Documents

- [483 - 2017-05-19](https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/fc2de3cc-6f44-43d9-8878-8f1a52a74db6)
- [EIR - 2017-05-19](https://www.keypedia.com/records/eir/catalent-pharma-solutions-llc/4e020e65-e96a-4055-8975-c8fc92b80ce4)
- [483 - 2019-03-04](https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/fd4377a5-e6b2-433a-984b-3eaa4c1481aa)
- [EIR - 2019-12-20](https://www.keypedia.com/records/eir/catalent-pharma-solutions-llc/a21c51b5-f6d4-45f8-81b9-1d807e1c09cc)
- [483 - 2020-09-28](https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/d907b32b-1a38-4df3-97fc-d0a2b5622a07)

## Related Officers

- [Harrison E. Tandy](https://www.keypedia.com/people/harrison-e-tandy/9c5aefee-952e-4996-8fd9-c15a7e15106d)
- [Ashley N. Samuel](https://www.keypedia.com/people/ashley-n-samuel/f98c1579-bf33-499e-89d0-62e394e6ee91)
- [Tanya R. Syffrard](https://www.keypedia.com/people/tanya-r-syffrard/a78a42b3-6cef-46d9-9698-ec6082956477)

Company: https://www.keypedia.com/companies/catalent-pharma-solutions-llc/1080c7fd-2536-4ea5-9a11-18fc6317081b

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7