# FDA 483 - Delta Pharma, Inc. - February 23, 2017

Source: https://www.keypedia.com/records/483/delta-pharma-inc/5ac7b857-fdf7-4f64-b81f-57bb52eb11b4

> FDA 483 for Delta Pharma, Inc. on February 23, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Delta Pharma, Inc.
- Inspection Date: 2017-02-23
- Product Type: Drugs
- Office Name: New Orleans District Office
- Summary: The FDA Form 483 details numerous deficiencies at an unnamed facility producing injectable drug products.

**Sterilization and Depyrogenation Validation:**
*   The firm failed to validate the sterilization process for non-sterile (b)(4) used in finished injectable products.
*   The cleaning and sterilization process for (b)(4) of finished injectable drug products was not validated.
*   Sterilization processes for non-sterile wipes, sponges, and mop heads used in ISO 5, 7, and 8 areas, including their reuse, were not validated.
*   Sterilization (b)(4) for (b)(4) used in injectable drug production were not validated.
*   The depyrogenation process for (b)(4) sodium chloride (NaCl) using an (b)(4) was not validated.
*   Depyrogenation (b)(4) using an (b)(4) for finished product containers (amber glass vials) and glassware were not validated.
*   The cleaning process for glassware using household dish soap was not validated.

**Aseptic Processing and Environmental Control:**
*   Media fills were not performed by all operators, nor did they simulate actual processing conditions (e.g., largest batch size, all manipulations).
*   Post-production (b)(4) repeatedly failed to meet manufacturer specifications, with no investigations performed, and batches released (e.g., Benadram lot

## 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 - 2022-05-20](https://www.keypedia.com/records/483/delta-pharma-inc/d2e11fc5-fe79-44c2-af6d-c3630eeda284)

## Related Officers

- [Brandon C. Heitmeier](https://www.keypedia.com/people/brandon-c-heitmeier/09e1b64b-01de-4f8b-819a-1179d8b4c0c1)
- [Investigator](https://www.keypedia.com/people/shelby-n-marler/2cbb1b1c-ad36-4385-b61f-bee80ad8e1bd)
- [Senior Advisor](https://www.keypedia.com/people/diane-p-goyette/e1f55d42-cb53-4872-aae0-44a442a0022b)

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