# FDA 483 - John L. McClellan Memorial Veterans Hospital - January 23, 2020

Source: https://www.keypedia.com/records/483/john-l-mcclellan-memorial-veterans-hospital/0e4b8824-c2ea-4421-a420-cc6ce178b839

> FDA 483 for John L. McClellan Memorial Veterans Hospital on January 23, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: John L. McClellan Memorial Veterans Hospital
- Inspection Date: 2020-01-23
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: This FDA Form 483 document details observations from an inspection of John L. McClellan Memorial Veterans Hospital, a producer of sterile drug products, located at 4300 W 7th St Rm 1D100, Little Rock, AR 72205-5446. The inspection occurred from January 13-17, 2020, and January 21-23, 2020. Dr. Margie A. Scott, Medical Center Director, was the individual to whom the report was issued.

The inspection revealed eight observations:

1.  **Non-sterile Disinfecting Agents and Wipes:** Disinfecting agents and cleaning wipes used in ISO 5 classified aseptic processing areas were not sterile. This included non-sterile [b)(4)] used for routine cleaning of biological safety cabinets (ISO-5), non-sterile bactericidal [b)(4)] cleaning solution for routine cleanings of classified areas, and non-sterile [b)(4)] Wipes [b)(4)] used as a fungicidal for material transfer into aseptic operations. The firm produces various sterile drug products, including intravenous, subcutaneous, and intrathecal routes of administration.

2.  **Inadequate Product Evaluation and Remedial Action for Microbial Contamination:** The firm did not adequately evaluate and take remedial action when actionable microbial contamination (11 CFUs of Gram-positive rods, micrococ

## Related Documents

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Company: https://www.keypedia.com/companies/john-l-mcclellan-memorial-veterans-hospital/0ed972a3-085b-4650-93e3-1b7beaafe7d9

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