# FDA 483 - Abrams Royal Pharmacy - December 20, 2013

Source: https://www.keypedia.com/records/483/abrams-royal-pharmacy/b5b32bee-ba64-4ca1-a7a6-d64b154bd086

> FDA 483 for Abrams Royal Pharmacy on December 20, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abrams Royal Pharmacy
- Inspection Date: 2013-12-20
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: The FDA Form 483 details multiple deficiencies at a facility manufacturing sterile human drug products.

**Facility and Operations:** The firm operates a clean room (ISO 7) with laminar flow hoods (ISO 5) and an anteroom (ISO 8). Products like Glutathione MDV, Methionin/Choline Blend, Calcium Edetate, and Glycyrrhizic Acid are sterilized.

**Violations and Observations:**
*   **Aseptic Technique:** Technicians exhibited poor aseptic techniques, including touching sterile surfaces with non-sterile gloves, picking items off the floor, exposed skin at wrists, improper mouth/nose cover, torn gowns, and re-entering the clean room without changing gloves/gowns. Non-sterile gown clothing was also used.
*   **Sterility Testing & Release:** Drug products purporting to be sterile are not consistently tested for sterility and pyrogen-free requirements before release. Examples show products shipped before sterility results were received. In-use filters for sterilization were not tested.
*   **Environmental Control & Design:** The clean room and anteroom lack suitable construction for aseptic operations, including inadequate air pressure differential and cascade. Smoke studies to verify unidirectional airflow in ISO 5 hoods and rooms are not performed. The anteroom lacks air supply ducts and is separated by plastic strips, not a continuous barrier.
*   **Quality Control Unit Authority:** The QC unit fails to fully investigate sterility failures (6 of 1

## Related Documents

- [WARNING_LETTER - 2013-12-20](https://www.keypedia.com/records/warning_letter/abrams-royal-pharmacy/f46d63c4-8a57-4288-b505-e24c0f384576)

## Related Officers

- [Scott T. Ballard](https://www.keypedia.com/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)
- [Investigator](https://www.keypedia.com/people/elisa-m-fleming/bfb8308a-9b37-4051-90f2-66066c26e1f4)

Company: https://www.keypedia.com/companies/abrams-royal-pharmacy/3cf83e95-93a9-4931-8e72-238282b33bbb

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9