# FDA 483 - Pharmaceutics International, Inc. - October 30, 2020

Source: https://www.globalkeysolutions.net/records/483/pharmaceutics-international-inc/b1b883c2-e23c-45a1-9762-e36d6a7222af

> FDA 483 for Pharmaceutics International, Inc. on October 30, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmaceutics International, Inc.
- Inspection Date: 2020-10-30
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Pharmaceutics International, Inc. in Cockeysville, MD, a sterile drug manufacturer, was inspected from October 19-30, 2020. The inspection revealed significant deficiencies in aseptic processing procedures, including unsuitable environmental monitoring equipment and unreviewed particle excursions. The firm also failed to establish time limits for critical production phases and exhibited multiple failures within its Quality Control Unit, such as overdue CAPAs, undocumented equipment failures, and inadequate temperature monitoring.

## Related Documents

- [483 - 2016-04-04](https://www.globalkeysolutions.net/records/483/pharmaceutics-international-inc/6fb09bb0-c571-4f95-9373-92e75ada3ab8)
- [483 - 2017-10-27](https://www.globalkeysolutions.net/records/483/pharmaceutics-international-inc/1072b5e6-ef5e-404d-a0b3-54063b982137)
- [483 - 2020-07-10](https://www.globalkeysolutions.net/records/483/pharmaceutics-international-inc/1f4d0f6f-9d88-4271-9537-82cbb1c04111)
- [483 - 2021-09-29](https://www.globalkeysolutions.net/records/483/pharmaceutics-international-inc/98c0fefd-6d0c-4a86-ac7d-593085f5d47e)
- [EIR - 2022-11-14](https://www.globalkeysolutions.net/records/eir/pharmaceutics-international-inc/ef206f73-a4e1-444d-aae9-d09577c023c9)

## Related Officers

- [Yvins Dezan](https://www.globalkeysolutions.net/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)
- [Investigator](https://www.globalkeysolutions.net/people/junho-pak/4abe53fb-ad20-490d-9e71-6216a9f863f5)

Company: https://www.globalkeysolutions.net/companies/pharmaceutics-international-inc/38fdf7bd-a7f3-486e-b74d-13b87414922e

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e