# FDA 483 - Gingi-Pak A Division of the Belport Co., Inc - November 12, 2021

Source: https://www.keypedia.com/records/483/gingi-pak-a-division-of-the-belport-co-inc/4c370aa3-fb14-4f63-be54-f61ccf5dd77f

> FDA 483 for Gingi-Pak A Division of the Belport Co., Inc on November 12, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gingi-Pak A Division of the Belport Co., Inc
- Inspection Date: 2021-11-12
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Belport Co Inc. dba Gingi-Pak in Camarillo, CA, a drug manufacturer, revealed significant deficiencies in their quality systems. Observations included a lack of microbiological testing for water and drug products, inadequate investigations into out-of-specification results, and a missing stability testing program. The firm also failed to qualify equipment, properly document packaging and cleaning activities, and maintain complete batch production records.

## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.keypedia.com/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)

Company: https://www.keypedia.com/companies/gingi-pak-a-division-of-the-belport-co-inc/bd9c5700-b0b8-47ae-b992-bef080ddd49e

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6