# FDA 483 - Brown's Compounding Center, Inc. - April 27, 2015

Source: https://www.globalkeysolutions.net/records/483/browns-compounding-center-inc/3197d53e-e8a6-4fd7-a40d-35f8ae8b7e31

> FDA 483 for Brown's Compounding Center, Inc. on April 27, 2015. 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: 2015-04-27
- Product Type: Drugs
- Office Name: Denver District Office
- Summary: The FDA inspection of an outsourcing facility revealed multiple deficiencies in its production, process controls, and quality systems.

**Facility and Operations:** The facility compounds various drug products, including Papaverine HCL, testosterone cypionate, hydroxyprogesterone, lipolean, methylcobalamin, fentanyl, hydromorphone, fentanyl/bupivacaine, phenylephrine, norepinephrine, magnesium sulfate, and dimethyl sulfoxide/dimethyl sulfone.

**Violations and Observations:**

*   **Lack of Written Procedures:** No written procedures exist for production and process controls to ensure drug product identity, strength, quality, and purity. Specifically, Papaverine HCL 30 mg/ml stock solution was frozen and re-thawed four times despite refrigeration instructions, with no assurance of stability after reuse. There are no established procedures for the use and manufacture of sterile stock solutions.
*   **Microbiological Contamination Prevention:** Procedures to prevent microbiological contamination of sterile drug products are not established. Post-production testing was not conducted on equipment used for 16 lots of aqueous and oil/aqueous drug products.
*   **Product Release Testing:** Testing and release of drug products for distribution do not include appropriate laboratory determination of satisfactory conformance to final specifications. A visual inspection of Lipolean lot 02242015-185607 was not performed with a contrasting white/black background as required, and the SOP did not reference this. No

## Related Documents

- [483 - 2014-07-31](https://www.globalkeysolutions.net/records/483/browns-compounding-center-inc/fda571ae-542d-46c0-b0aa-6d11c7e31a62)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/tomika-l-bivens/089d8723-f740-40ed-a4b9-4619edc4e5cd)
- [Compliance Officer / Investigator](https://www.globalkeysolutions.net/people/erika-v-butler/3e654530-4c29-403d-880e-a5422315c3c0)

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

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face