# FDA 483 - US Compounding Inc - July 15, 2016

Source: https://www.keypedia.com/records/483/us-compounding-inc/a2745f8b-d565-42f9-96a9-f4f2e5741aeb

> FDA 483 for US Compounding Inc on July 15, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: US Compounding Inc
- Inspection Date: 2016-07-15
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: The FDA Form 483 details significant deficiencies in aseptic processing, environmental monitoring, facility design, and quality control at the inspected facility.

**Environmental Monitoring Deficiencies:**
*   Failure to investigate increasing mold recoveries from March to June 2016.
*   Lack of investigation or action for large, fuzzy mold colonies observed on environmental monitoring plates.
*   Inconsistent surface sampling practices (e.g., operators conducting sampling directly above surfaces).
*   Environmental monitoring using plates was only conducted in an unused, cleaned cleanroom for the week of 07/04/2016.
*   Inability to demonstrate the effectiveness of operator glove sanitization.

**Aseptic Processing Area Deficiencies (Air Supply/Pressure):**
*   Routine failure to maintain pressure differentials, with frequent excursions (e.g., negative pressure between ISO 7 Cleanroom and ISO 7 Anteroom during processing of Methylprednisolone Acetate PF).
*   Missing time points in pressure logs (e.g., 29% missing on 05/02/2016 during processing of Neostigmine Methylsulfate and MIC # B12 lots).
*   Failure to investigate pressure excursions (e.g., Methylprednisolone Acetate PF lot #20160109@3 distributed without investigation).
*   Failure to capture pressure differential losses on document QF

## Related Documents

- [483 - 2015-08-21](https://www.keypedia.com/records/483/us-compounding-inc/61bfcc83-b24f-4171-a13c-611f0bd338b6)
- [483 - 2014-03-27](https://www.keypedia.com/records/483/us-compounding-inc/722e591e-6d7f-41cf-a2b3-93b2f590fba3)
- [483 - 2019-02-07](https://www.keypedia.com/records/483/us-compounding-inc/236a759f-42c0-4e30-86a9-d45eca34e97b)

## Related Officers

- [Scott T. Ballard](https://www.keypedia.com/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)
- [Biologist at CBER](https://www.keypedia.com/people/massoud-motamed/a8b363de-eb95-4bd3-8c05-9c34bbdbdc8a)

Company: https://www.keypedia.com/companies/us-compounding-inc/76f78f4e-f548-4f5f-bd15-1353344f1f0f

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