# FDA 483 - Green Hills Health and Wellness Pharmacy Inc - June 30, 2016

Source: https://www.keypedia.com/records/483/green-hills-health-and-wellness-pharmacy-inc/dda28958-692c-4441-97ab-eefc2febeb83

> FDA 483 for Green Hills Health and Wellness Pharmacy Inc on June 30, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Green Hills Health and Wellness Pharmacy Inc
- Inspection Date: 2016-06-30
- Product Type: Drugs
- Summary: On June 30, 2016, the FDA issued a Form 483 to Health & Wellness Compounding Pharmacy, a producer of sterile drugs located at 329 21st Ave N, Suite 3, Nashville, TN 37203-1839. The inspection, conducted from June 14 to June 30, 2016, identified one observation.

The observation noted that drug product containers were not sterilized and processed to remove pyrogenic properties to assure suitability for their intended use. Specifically, the firm does not depyrogenate glassware used for mixing drug products intended to be sterile. The report was issued to Mark F. Binkley, the owner of the firm. The inspection was conducted by Investigators Zada L. Giles and Meocha V. Whaley.

## Related Documents

- [WARNING_LETTER - 2014-10-22](https://www.keypedia.com/records/warning_letter/green-hills-health-and-wellness-pharmacy-inc/988b40ca-d58e-4047-81b6-948e3de11c8e)
- [483_RESPONSE - 2014-10-22](https://www.keypedia.com/records/483_response/green-hills-health-and-wellness-pharmacy-inc/45a6b74e-62f0-46db-bb38-00ad96607ae9)
- [483 - 2014-10-22](https://www.keypedia.com/records/483/green-hills-health-and-wellness-pharmacy-inc/da951786-633b-4d55-b26a-07d7a0afa4a5)
- [STATE_REFERRAL_LETTER - 2016-06-14](https://www.keypedia.com/records/state_referral_letter/green-hills-health-and-wellness-pharmacy-inc/290e5fcc-c898-4bf8-a5cd-c615c24bebf8)

## Related Officers

- [Supervisory Investigator at FDA](https://www.keypedia.com/people/zada-l-giles/29930e94-66c8-4d36-9220-b2ecbfe12351)
- [Investigator](https://www.keypedia.com/people/meocha-v-whaley/b687110f-3a60-4414-9ca4-0805894b2374)

Company: https://www.keypedia.com/companies/green-hills-health-and-wellness-pharmacy-inc/16296d4f-ee6d-434f-9c27-aa9d38ddcd3b