# FDA 483 - Isomeric Pharmacy Solutions, LLC - June 29, 2016

Source: https://www.keypedia.com/records/483/isomeric-pharmacy-solutions-llc/8715c207-32c9-4a6c-84a0-45cbb1cae594

> FDA 483 for Isomeric Pharmacy Solutions, LLC on June 29, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Isomeric Pharmacy Solutions, LLC
- Inspection Date: 2016-06-29
- Product Type: Drugs
- Office Name: Denver District Office
- Summary: The FDA Form 483 details numerous deficiencies at an outsourcing facility producing sterile injectable drug products.

**Key Violations and Observations:**

*   **Inadequate Investigations:**
    *   Investigations into unexplained discrepancies and batch failures (e.g., MedWatch adverse event EN-16001, HCG potency failures, Beta combo appearance failures, MP40 clumping complaints) lacked conclusions, follow-up, root cause identification, and corrective actions.
    *   Non-viable particle excursions during triamcinolone production were not evaluated in the MedWatch complaint investigation.
    *   No investigations were conducted for two HCG lots failing internal potency specifications, which were subsequently released.
    *   Repeated Beta combo appearance failures and subsequent customer complaints (EN-160002, EN-160004) lacked adequate investigation and CAPA.
    *   Six MP40 customer complaints (EN-160005, EN-160006, EN-160007, EN-160008, EN-16009, EN-16003) regarding clumping and sticking issues were not adequately investigated, despite both batches being sterilized using a specific method.

*   **Environmental Monitoring Deficiencies:**
    *   Negative environmental monitoring trends (e.g., MEF 1605001

## Related Documents

- [483 - 2017-03-24](https://www.keypedia.com/records/483/isomeric-pharmacy-solutions-llc/65bdc385-e448-4259-b8c9-4be8bc9244c6)
- [483 - 2015-08-28](https://www.keypedia.com/records/483/isomeric-pharmacy-solutions-llc/70af8e2f-8a1c-4ff0-9067-2999970c8a1a)
- [483_RESPONSE - 2015-08-28](https://www.keypedia.com/records/483_response/isomeric-pharmacy-solutions-llc/ae176860-649c-4c53-8c15-125876cac68b)

## Related Officers

- [Jamie L. C. Dion](https://www.keypedia.com/people/jamie-l-c-dion/bea1370f-d56e-4eb1-8026-fcdec73d6eae)
- [Supervisory microbiologist](https://www.keypedia.com/people/zachery-l-miller/e7ff2001-1e81-4483-9e9b-288b7e92c719)

Company: https://www.keypedia.com/companies/isomeric-pharmacy-solutions-llc/31bf3684-1983-4753-8f48-16c5b9563eca

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face