# FDA 483 - Honest Globe, Inc. - October 08, 2019

Source: https://www.globalkeysolutions.net/records/483/honest-globe-inc/9a14a72e-a5cd-48b8-b713-ef4e9ad27ad3

> FDA 483 for Honest Globe, Inc. on October 08, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Honest Globe, Inc.
- Inspection Date: 2019-10-08
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Norquest Globe, Inc., an OTC drug manufacturer in Santa Ana, CA, was cited for significant deficiencies across its quality system, laboratory controls, facilities, equipment, and packaging/labeling. Key issues include an inadequate Quality Control Unit, lack of annual product reviews, absence of a change control program, and failure to investigate out-of-specification results. The firm also lacked validated stability programs, consistent microbiological testing, validated cleaning procedures, and proper equipment qualification.

## Related Documents

- [WARNING_LETTER - 2019-10-08](https://www.globalkeysolutions.net/records/warning_letter/honest-globe-inc/4ec026f2-2887-4708-9b35-2f3fef6b6307)

## Related Officers

- [Alan L. Truong](https://www.globalkeysolutions.net/people/alan-l-truong/8b9c59ed-ce68-44c3-9fbe-07cc3da13713)

Company: https://www.globalkeysolutions.net/companies/honest-globe-inc/028a6a8d-de7d-42f9-b230-25fa08dd3886

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