# FDA WARNING_LETTER - Beacon Hill Medical Pharmacy, P.C. - July 19, 2013

Source: https://www.keypedia.com/records/warning_letter/beacon-hill-medical-pharmacy-pc/684d3f72-43f0-4735-92c9-05a03cc55306

> FDA WARNING_LETTER for Beacon Hill Medical Pharmacy, P.C. on July 19, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Beacon Hill Medical Pharmacy, P.C.
- Inspection Date: 2013-07-19
- Product Type: Drugs
- Office Name: Detroit District Office
- Summary: On September 24, 2014, the FDA issued a Warning Letter to Beacon Hill Medical Pharmacy, P.C. (dba) Rxtra Solutions Labs following an inspection from July 1-19, 2013. The inspection revealed the firm was producing drug products without valid prescriptions for individually-identified patients and had serious deficiencies in sterile drug product manufacturing, posing patient risks.

Key violations included:
- **Lack of Valid Prescriptions:** A portion of drug products were produced and distributed without valid prescriptions for individually-identified patients, making them unapproved new drugs (Section 505(a) FDCA) and misbranded drugs (Section 502(f)(1) FDCA).
- **Insanitary Conditions:** Sterile drug products were prepared, packed, or held under insanitary conditions, leading to adulteration (Section 501(a)(2)(A) FDCA). Examples include cleaning aseptic areas with soap, tap water, and non-sterile disinfectants; using non-sterile gloves for manual vial stoppering; and transferring partially stoppered vials unprotected to an unclassified area.
- **CGMP Violations:** Significant Current Good Manufacturing Practice (CGMP) violations were observed, causing drug products without individual prescriptions to be adulterated (Section 501(a)(2)(B) FDCA). These included failures in:
    - Establishing and following written procedures to prevent microbiological

## Related Documents

- [483 - 2013-07-19](https://www.keypedia.com/records/483/beacon-hill-medical-pharmacy-pc/6f4f4cc7-00d2-4083-9329-47d95efd91a4)

## Related Officers

- [Program Division Director](https://www.keypedia.com/people/art-o-czabaniuk/37f1e249-9ee6-4275-9c28-391d93659b85)
- [Compliance Officer](https://www.keypedia.com/people/tina-m-pawlowski/6d07c117-7a52-4640-b2cf-530fa1bd4557)

Company: https://www.keypedia.com/companies/beacon-hill-medical-pharmacy-pc/a1383ab4-b75b-44a3-8be3-0ce3efcc25c2

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03