# FDA 483 - Herbal Doctor Remedies - April 19, 2019

Source: https://www.globalkeysolutions.net/records/483/herbal-doctor-remedies/c1608039-f486-4257-8f7b-7aa497b36638

> FDA 483 for Herbal Doctor Remedies on April 19, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Herbal Doctor Remedies
- Inspection Date: 2019-04-19
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Herbal Doctor Remedies in Monterey Park, CA, was inspected and cited for numerous significant deficiencies across its manufacturing operations. The firm lacks a functional quality control unit, validated processes, proper record-keeping, and essential testing for identity, strength, and stability of drug products. These issues indicate a severe lack of adherence to current good manufacturing practices.

## Related Documents

- [WARNING_LETTER - 2019-04-19](https://www.globalkeysolutions.net/records/warning_letter/herbal-doctor-remedies/d255d793-d67a-4748-a1fd-1def664c1cf7)

## Related Officers

- [Anita Narula, Ph.D., CSO - Biotechnology](https://www.globalkeysolutions.net/people/anita-narula-phd-cso-biotechnology/58c5451d-046e-42a0-87f1-ff9b277ef60e)
- [Diane J Weidley, Generic Drug User Fee Amendments (GDUFA)](https://www.globalkeysolutions.net/people/diane-j-weidley-generic-drug-user-fee-amendments-gdufa/fe191616-e828-4c3c-8091-bc09d186de4b)

Company: https://www.globalkeysolutions.net/companies/herbal-doctor-remedies/7adaa414-02d8-4442-9e8c-767b5064a0d7

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