# FDA 483 - Be Well Natural Medicine - May 20, 2022

Source: https://www.keypedia.com/records/483/be-well-natural-medicine/01385512-618f-4dd6-ae28-b7727e3ea55c

> FDA 483 for Be Well Natural Medicine on May 20, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Be Well Natural Medicine
- Inspection Date: 2022-05-20
- Product Type: Drugs
- Office Name: San Francisco District Office
- Summary: During an inspection conducted from May 2 to May 20, 2022, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Be Well Natural Medicine, a producer of sterile drugs. The observations highlighted significant deviations from expected manufacturing practices, indicating conditions where sterile drug products may be at risk of contamination, as outlined under the Federal Food, Drug and Cosmetic Act. Key issues included a compromised aseptic processing environment where the ISO 5 classified Laminar Flow Workstation was situated within an unclassified room. This surrounding area contained numerous particle-generating items like a vacuum cleaner and cardboard, alongside hard-to-clean surfaces such as carpet and textured walls. Furthermore, there was no documentation verifying the workstation met operational standards. Personnel involved in sterile drug preparation were observed using non-sterile gloves and inadequate gowning, failing to cover wrists, hair, and mouth. Materials entering the aseptic area were not disinfected, and non-sterile absorbent cloths were used and improperly stored. Finally, appropriate sporicidal agents were not employed for cleaning cleanrooms or the aseptic processing area, relying instead on non-sporicidal cleaners. The firm is expected to implement comprehensive corrective actions to address these critical findings and ensure the sterility and safety of its drug products.

## Related Officers

- [Investigator](https://www.keypedia.com/people/jolanna-a-norton/5501fea4-4bfd-434c-b2aa-fcf94444f684)
- [Consumer Safety Officer](https://www.keypedia.com/people/dustin-m-james/bf423ddc-721b-4049-9eb1-3bc0fdb44441)

Company: https://www.keypedia.com/companies/be-well-natural-medicine/8e32d865-63dd-464b-a5b4-304ec1593507

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df