# FDA 483 - Pharmaceutics International Inc - December 06, 2024

Source: https://www.keypedia.com/records/483/pharmaceutics-international-inc/e2e84415-5d23-4319-901b-b9bbb7761500

> FDA 483 for Pharmaceutics International Inc on December 06, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmaceutics International Inc
- Inspection Date: 2024-12-06
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: Pharmaceutics International Inc in Hunt Valley, MD, was inspected and received a Form 483 with four observations, two of which were repeat observations. The inspection revealed deficiencies in equipment cleaning validation, supplier qualification for API microbiological testing, instrument calibration procedures for HPLC systems, and overall equipment qualification and control. These issues indicate significant concerns regarding the firm's quality control and manufacturing processes.

## Related Documents

- [EIR - 2022-11-14](https://www.keypedia.com/records/eir/pharmaceutics-international-inc/2adaea6c-1bf7-4220-a187-496f2233d83b)
- [483 - 2018-11-09](https://www.keypedia.com/records/483/pharmaceutics-international-inc/9e005824-a2d7-45ef-897c-1a863e8ef353)
- [483 - 2016-03-18](https://www.keypedia.com/records/483/pharmaceutics-international-inc/073299e1-26d0-4892-a7f1-668a441df51b)
- [483 - 2017-11-16](https://www.keypedia.com/records/483/pharmaceutics-international-inc/c0dca8aa-b540-4ad9-9302-54d60c3b66e2)
- [483 - 2020-10-30](https://www.keypedia.com/records/483/pharmaceutics-international-inc/0646990d-3723-4aaf-8660-3f93d931b33b)

## Related Officers

- [Pharmacy Intern/Certified Pharmacy Technician](https://www.keypedia.com/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)
- [Young K. Chou](https://www.keypedia.com/people/young-k-chou/3f34cb70-7f30-453d-9099-885e1b168975)
- [Investigator](https://www.keypedia.com/people/lu-chen/d0700911-c592-4da7-a445-5dfb2a4bedff)

Company: https://www.keypedia.com/companies/pharmaceutics-international-inc/89d3a795-b80a-4c2b-81fe-20abd08cf281

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