# FDA 483 - Sharp Drugs, Inc. - July 13, 2018

Source: https://www.keypedia.com/records/483/sharp-drugs-inc/c8dcfb10-2cba-4d54-a912-48ac722a285d

> FDA 483 for Sharp Drugs, Inc. on July 13, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sharp Drugs, Inc.
- Inspection Date: 2018-07-13
- Product Type: Drugs
- Office Name: New York District Office
- Summary: This FDA Form 483 documents observations from an inspection concerning the production of Deferoxamine 2.5gm IV. The facility's ISO 5 classified aseptic processing area, specifically a biological safety cabinet, is located within a non-classified room lacking HEPA filtration. The hood is powered off when not in use, exposed to unclassified air, and not re-cleaned before production. This unclassified room is separated by a wooden door with a hole.

Disinfecting agents, cleaning pads, and wipes used in the ISO 5 area were not sterile; specifically, non-sterile (b)(4) and disposable paper towels were used for cleaning the biological safety cabinet, and non-sterile (b)(4) wipes were used on vials and IV bag ports. No sporicidal agent was used. Personnel engaged in aseptic processing, including the owner who performs all sterile processing, wore non-sterile nitrile gloves.

The facility has not performed any media fills to simulate aseptic production operations, including worst-case activities and conditions. Materials and supplies, specifically (b)(4) and Deferoxamine 2gm vials, were not disinfected prior to entering the aseptic processing area. Furthermore, environmental monitoring was not performed in the aseptic processing areas.

## Related Officers

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Company: https://www.keypedia.com/companies/sharp-drugs-inc/514c5f6a-d54c-47e7-bf9c-e7a552270fd4

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d