# FDA 483 - Valgene Incorporated dba Cape Drugs - December 02, 2021

Source: https://www.globalkeysolutions.net/records/483/valgene-incorporated-dba-cape-drugs/8ceb6ae5-e71f-4733-befc-d2f765413f94

> FDA 483 for Valgene Incorporated dba Cape Drugs on December 02, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Valgene Incorporated dba Cape Drugs
- Inspection Date: 2021-12-02
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Valgene Incorporated dba Cape Drugs in Annapolis, MD, a producer of sterile and non-sterile drug products, revealed significant deficiencies in aseptic processing and facility controls. Observations included insufficient disinfectant contact time, difficult-to-clean surfaces with exposed particle-generating materials, and facility design flaws allowing poor quality air into classified areas. Additionally, ISO 5 classified areas were not properly certified under dynamic conditions, indicating a high risk to sterile product quality.

## Related Documents

- [483 - 2015-10-07](https://www.globalkeysolutions.net/records/483/valgene-incorporated-dba-cape-drugs/ebfd511d-906b-4b81-a985-aa7aa4b79160)
- [483 - 2018-01-22](https://www.globalkeysolutions.net/records/483/valgene-incorporated-dba-cape-drugs/4123daeb-777d-4d09-94f9-5dadbf666ea8)
- [483 - 2021-12-02](https://www.globalkeysolutions.net/records/483/valgene-incorporated-dba-cape-drugs/927dcfbd-c79a-4c7a-b652-20efc3e4d4f2)
- [UNTITLED_LETTER - 2022-11-03](https://www.globalkeysolutions.net/records/untitled_letter/valgene-incorporated-dba-cape-drugs/311b1ca0-ab67-412e-9e5c-f7f10135d128)

## Related Officers

- [Sena G. Dissmeyer](https://www.globalkeysolutions.net/people/sena-g-dissmeyer/4dbb1255-95e4-402b-8bb3-75c4f7940c13)
- [Kathleen M. Jordan](https://www.globalkeysolutions.net/people/kathleen-m-jordan/e08b786a-47bf-4e78-ae96-9d94cdc20bdb)

Company: https://www.globalkeysolutions.net/companies/valgene-incorporated-dba-cape-drugs/6f3fdd19-6478-4651-aa62-4123d5f53c49

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64