# FDA 483 - Healthy Choice Compounding LLC - February 28, 2017

Source: https://www.keypedia.com/records/483/healthy-choice-compounding-llc/6f0d0e15-6411-4b37-bfc9-b242f30edb7a

> FDA 483 for Healthy Choice Compounding LLC on February 28, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Healthy Choice Compounding LLC
- Inspection Date: 2017-02-28
- Product Type: Drugs
- Office Name: New York District Office
- Summary: An FDA inspection conducted on February 22, 24, and 28, 2017, at Jacobs Pills, Inc. d/b/a The Healthy Choice Apothecary, identified a significant observation regarding quality control. The inspection, carried out under the regulatory framework for non-sterile drug producers, revealed a failure to thoroughly review unexplained discrepancies, even after product distribution. Specifically, the firm did not adequately review compounding records to ensure that all ingredients used in drug products were within their expiry dates. A key example cited involved the use of Sildenafil. The document details instances on August 1, 2016, November 2, 2016, and December 19, 2016, where Sildenafil was used to compound various Sildenafil 100 mg capsules and suppositories. These compounded products were subsequently dispensed or shipped to patients, despite the apparent failure to verify the expiry status of the raw material. This observation highlights a breakdown in quality assurance processes essential for ensuring patient safety and product efficacy. Jacobs Pills, Inc. is required to respond to the FDA with a plan for corrective actions to address this observation and prevent recurrence, or to provide an objection to the findings.

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## Related Officers

- [Mindy M. Chou](https://www.keypedia.com/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)

Company: https://www.keypedia.com/companies/healthy-choice-compounding-llc/6ed01710-4033-40b2-8736-0630cc237e1e

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d