# FDA 483 - American Specialty Pharmacy - August 05, 2015

Source: https://www.keypedia.com/records/483/american-specialty-pharmacy/ad803bbb-0944-4d68-ad1d-813e0749ad82

> FDA 483 for American Specialty Pharmacy on August 05, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Specialty Pharmacy
- Inspection Date: 2015-08-05
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: From July 29 to August 5, 2015, the FDA inspected American Specialty Pharmacy, a producer of sterile drug products located at 10 Medical Pkwy Ste 105, Dallas, TX 75234-7838. The inspection, issued to owner Abdul Hameed, revealed ten observations regarding deficiencies in sterile drug product manufacturing.

Key violations include:
1.  **Microbiological Contamination Prevention:** Procedures to prevent microbiological contamination were not followed. This included failure to disinfect components before bringing them into the ISO 5 hood, use of non-sterile absorbent pads, opening sterile wipes in a non-ISO 5 area, and technicians not re-spraying gloves with sterile alcohol after moving hands in and out of the ISO 5 hood.
2.  **Aseptic Processing Area Monitoring:** Environmental monitoring of aseptic processing areas was deficient. Only initial monitoring of ISO 5 and Laminar Flow was performed since January 2015, with no additional monitoring. Initial qualification showed out-of-compliance results for two locations with no documented investigation. The firm also failed to conduct environmental monitoring at required frequencies per SOP.
3.  **Protective Apparel:** Non-sterile protective apparel (facemask, shoe covers, hair covers, disposable lab coat, and no sterile eye goggles) was worn during sterile product preparation, exposing facial skin.
4.  **Cleaning and Disinfecting

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Company: https://www.keypedia.com/companies/american-specialty-pharmacy/70162c7f-78c7-47ce-8873-064f7ba73781

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