# FDA 483 - Brookfield Prescription Center Inc. dba MD Custom Rx - December 13, 2013

Source: https://www.keypedia.com/records/483/brookfield-prescription-center-inc-dba-md-custom-rx/35305264-643b-481f-963d-370f90042046

> FDA 483 for Brookfield Prescription Center Inc. dba MD Custom Rx on December 13, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Brookfield Prescription Center Inc. dba MD Custom Rx
- Inspection Date: 2013-12-13
- Product Type: Drugs
- Office Name: Minneapolis District Office
- Summary: This FDA Form 483 details inspectional observations made at Monica M. Zatarski PharmD, RPh, Compounding Pharmacist, Owner and President's facility in Minneapolis, MN, during inspections conducted from December 3-13, 2013.

**Key Observations and Violations:**

1.  **Microbiological Contamination Prevention:** Procedures for preventing microbiological contamination of sterile drug products are not established, written, or followed.
    *   SOP 9.110 (Sterile Compounding Process Validation/Media Fills) is inadequate and does not reflect actual practices (e.g., media fills not simulating actual compounding activities, technician filling 100 vials at 3.5 mL vs. 10 mL qualification, non-representative interventions).
    *   Sterilization processes are not validated, despite SOP 3.1112 requiring biological indicators for each load.

2.  **Failure to Review Batch Failures:** The firm failed to thoroughly review batches or components not meeting specifications.
    *   SOP 6.201 (Potency Testing) requires OOS investigation and recall determination, but a formal OOS investigation for Glycopyrrolate injection (notified Nov 12, 2013) had not been initiated by Dec 3, 2013.
    *   Four OOS investigations since January 2013 did

## Related Documents

- [WARNING_LETTER - 2013-12-10](https://www.keypedia.com/records/warning_letter/brookfield-prescription-center-inc-dba-md-custom-rx/730c2b0a-e285-4833-ac99-7ac56d40bd0c)

## Related Officers

- [Investigator](https://www.keypedia.com/people/jasjeet-k-sekhon/0dfa8aa8-ebe5-4182-81dc-8027667326f4)
- [Sandra A. Hughes](https://www.keypedia.com/people/sandra-a-hughes/ee1b9542-fe28-4618-a666-67a1ff736481)

Company: https://www.keypedia.com/companies/brookfield-prescription-center-inc-dba-md-custom-rx/b6675a9b-eea5-485b-b886-adc5ec82c40a

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d