# FDA WARNING_LETTER - One Way Drug, LLC - May 30, 2014

Source: https://www.keypedia.com/records/warning_letter/one-way-drug-llc/f6184a30-d9ce-43ec-9a80-0a2f8160df6b

> FDA WARNING_LETTER for One Way Drug, LLC on May 30, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: One Way Drug, LLC
- Inspection Date: 2014-05-30
- Product Type: Drugs
- Office Name: San Francisco District Office
- Summary: This FDA Warning Letter, dated July 22, 2015, was issued to One Way Drug, LLC dba Partell Specialty Pharmacy following an inspection from May 21-30, 2014. The inspection revealed serious deficiencies in sterile drug product production and non-compliance with federal regulations.

Key violations include:
- **Lack of Valid Prescriptions:** The firm produced drug products without valid prescriptions for individually-identified patients, violating Section 503A of the FDCA, rendering these drugs unapproved new drugs and misbranded.
- **Insanitary Conditions & Adulteration:** Sterile drug products were prepared under insanitary conditions, leading to adulteration under Section 501(a)(2)(A) of the FDCA. Specific observations included:
    - Operators stoppering vials with gloved hands on a partially separated table and processing sterile products with exposed skin.
    - Failure to use sporicidal agents for cleaning production areas.
    - Infrequent viable and non-viable monitoring.
    - Lack of continuous pressure differential monitoring.
    - Transfer of bulk drug product containers into ISO-5 area without sanitization.
    - Failure to demonstrate adequate protection of the ISO-5 area by the workbench.
- **CGMP Violations:** Significant Current Good Manufacturing Practice (CGMP) violations were observed, causing drugs to be adulterated under Section 501(a)(2

## Related Documents

- [483 - 2014-05-30](https://www.keypedia.com/records/483/one-way-drug-llc/458874c5-003d-475d-9d52-b9673a4bac1f)
- [483 - 2017-07-19](https://www.keypedia.com/records/483/one-way-drug-llc/32d8cc30-be13-4944-a7e9-32dd2ed20660)

## Related Officers

- [Executive Secretary](https://www.keypedia.com/people/larry-l-pinson/8d90d168-d23c-423b-bca7-b2647eae99b1)
- [Kathleen M. Lewis](https://www.keypedia.com/people/kathleen-m-lewis/c7f66b1a-d346-48cc-ab84-9ea6c2805268)

Company: https://www.keypedia.com/companies/one-way-drug-llc/f29ba890-7762-4f3b-bf3a-24d0eb4c9e11

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