# FDA 483 - Brown's Compounding Center, Inc. - July 31, 2014

Source: https://www.globalkeysolutions.net/records/483/browns-compounding-center-inc/fda571ae-542d-46c0-b0aa-6d11c7e31a62

> FDA 483 for Brown's Compounding Center, Inc. on July 31, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Brown's Compounding Center, Inc.
- Inspection Date: 2014-07-31
- Product Type: Drugs
- Summary: This FDA Form 483 details deficiencies at a facility producing sterile drug products, including Betamethasone Injection.

**Environmental Monitoring & Control:**
* **Microbial Contamination:** ISO 5 hoods, used for sterile filling, showed microbial failures in June/July 2014, but production continued without sufficient environmental monitoring frequency.
* **Pressure Differentials:** No written procedures or criteria for pressure differentials. The Aseptic Room (ISO 7) was 0.13 inches water gauge, while the adjacent Vial Washing Room (ISO 8) was 0.14, indicating the ISO 7 room was not positive to all adjacent rooms. Pressure differential for the pass room/box to a common hallway was unknown/unmonitored. No documentation of pressure differentials during production.
* **Monitoring Frequency:** Viable active air and non-viable particulates are not monitored during each daily production shift, only per schedule. Microbial contamination on ISO 5 work surfaces is also only scheduled, not associated with daily production.
* **Personnel Monitoring:** No personnel monitoring during aseptic filling operations. Microbiological personnel surface sampling (fingers, forearm, chest) is not conducted, only gloved hand contact plate testing.

**Aseptic Process & Validation:**
* **Media Fills:** Media fill procedures are inadequate. One sterile filling line (vials) has a media fill program, but the other method for Betamethasone Inj. does not.

## Related Documents

- [483 - 2015-04-27](https://www.globalkeysolutions.net/records/483/browns-compounding-center-inc/3197d53e-e8a6-4fd7-a40d-35f8ae8b7e31)

Company: https://www.globalkeysolutions.net/companies/browns-compounding-center-inc/f98bee09-9d66-4102-b051-c03346abfecc