# FDA 483 - Diabetes Corporation of America - June 15, 2017

Source: https://www.keypedia.com/records/483/diabetes-corporation-of-america/de16f904-220e-4440-a06f-1c6feea3d6df

> FDA 483 for Diabetes Corporation of America on June 15, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Diabetes Corporation of America
- Inspection Date: 2017-06-15
- Product Type: Drugs
- Summary: On June 5-15, 2017, the FDA inspected Diabetes Corporation of America dba DCA Pharmacy, a producer of sterile drugs, located at 233 Bedford Way, Franklin, TN. The inspection revealed five observations.

Observation 1 noted that cleaning pads or wipes used in the ISO 5 area were not sterile, specifically (b)(4) wipes used to clean the LAFH. Observation 2 identified difficult-to-clean, particle-generating, or visibly dirty equipment/surfaces in ISO-classified areas. A lyophilizer in the non-hazardous buffer room (ISO 7), adjacent to LAFH (ISO 5), contained (b)(4) with no procedures for external cleaning/disinfection. Environmental conditions for this room, including airflow and particle counts, were not evaluated during lyophilizer operation.

Observation 3 detailed personnel touching surfaces outside the ISO 5 area with gloved hands and proceeding with aseptic processing without changing or sanitizing gloves. This was observed on June 5, 2017, affecting lots T106/PGE-80/LIDO, RX (b)(5), (b)(7)(C), (b)(6), (b)(7)(C) and Phenylepherine/LIDO, RX (b)(5), (b)(7)(C). Observation 4 stated that drug products were released with strength, purity, or quality below purported levels.

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Company: https://www.keypedia.com/companies/diabetes-corporation-of-america/7fd329cd-cbf2-4a85-8a55-f1731936bfc6