# FDA 483 - Delta Pharma, Inc. - May 20, 2022

Source: https://www.keypedia.com/records/483/delta-pharma-inc/d2e11fc5-fe79-44c2-af6d-c3630eeda284

> FDA 483 for Delta Pharma, Inc. on May 20, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Delta Pharma, Inc.
- Inspection Date: 2022-05-20
- Product Type: Drugs
- Office Name: New Orleans District Office
- Summary: The FDA Form 483 details observations from an inspection, highlighting deficiencies in the facility's aseptic processing of drug products.

**Personnel Gowning and Contamination Control:** The firm's gowning location is inadequate, with face masks, head/beard covers, gloves, shoe covers, and gowns donned in a non-classified hallway before entering controlled areas (corridor, Room 3 (anteroom), and Room 2 (ISO 8)). The same shoe covers are worn in Room 3 and Room 2. Dedicated scrubs, worn in multiple areas including classified rooms and non-classified areas, are also a concern. This is a repeat observation from inspections in 2013, 2016, and 2017.

**Cleaning and Disinfection:** The stated contact disinfectant time for (b)(4) (10 minutes) conflicts with the manufacturer's recommended sporicidal contact time of 30 minutes, despite aligning with an internal cleaning efficacy study.

**Aseptic Processing Area Deficiencies:** During a media fill run on May 18, 2022, a bag of sterile rubber stoppers was improperly oriented in the ISO-5 laminar hood, with the opened end not exposed to first-pass air.

**Equipment Calibration and Monitoring:** Routine calibration of the automated (b)(4) is deficient. A media fill run on May 16, 2022, showed

## Related Documents

- [WARNING_LETTER - 2013-10-02](https://www.keypedia.com/records/warning_letter/delta-pharma-inc/7567285f-4554-4c30-9544-052cb0be4388)
- [483 - 2013-10-02](https://www.keypedia.com/records/483/delta-pharma-inc/77c6ff3a-c84e-4a29-a638-3471de3735ea)
- [483 - 2016-05-24](https://www.keypedia.com/records/483/delta-pharma-inc/38d1f9bd-5f69-41bf-b236-d69d6862e289)
- [483 - 2017-02-23](https://www.keypedia.com/records/483/delta-pharma-inc/5ac7b857-fdf7-4f64-b81f-57bb52eb11b4)

## Related Officers

- [Jennifer Lalama](https://www.keypedia.com/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)
- [Investigator](https://www.keypedia.com/people/regan-t-harp/f27e8e4f-2a75-4c4b-8c3e-f8f8ca0717f3)

Company: https://www.keypedia.com/companies/delta-pharma-inc/bf853940-f96e-48fc-86ef-9d87c68bc28b

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea