# FDA 483 - MOORE'S COMPOUNDING PHARMACY - January 13, 2017

Source: https://www.keypedia.com/records/483/moores-compounding-pharmacy/c9cb6cd7-0448-4339-bd5a-5295c947208c

> FDA 483 for MOORE'S COMPOUNDING PHARMACY on January 13, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MOORE'S COMPOUNDING PHARMACY
- Inspection Date: 2017-01-13
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: On January 13, 2017, the FDA issued a Form 483 to Moore's Compounding Pharmacy in Corpus Christi, TX, following an inspection from January 4-13, 2017. The facility is a producer of non-sterile drugs, and the report was issued to Mr. Kelby D. Gorman, Pharmacist In Charge.

The sole observation noted was a failure to follow procedures designed to prevent objectionable microorganisms in non-sterile drug products. Specifically, the firm's SOP 7.090, Version 1.0, "REQUIRED GARB FOR NON-STERILE COMPOUNDING AREA," effective November 1, 2014, mandates wearing sterile gloves or disinfecting non-sterile gloves with a sterile disinfectant.

However, on January 4, 2017, an FDA investigator observed a Certified Pharmacy Technician (CPT) handling ingredients for Tri-Est Progesterone capsules (Lot# 2017-01-03:63@16) with bare hands in the compounding hood. The CPT, who began compounding capsules around May 2015, stated they were trained to handle ingredients with bare hands before putting on non-sterile gloves. From October 1 to December 31, 2016, the firm prepared approximately [redacted] compounded capsule prescriptions. This indicates a systemic issue with adherence to established microbial

## Related Documents

- [145 - 2018-08-02](https://www.keypedia.com/records/145/moores-compounding-pharmacy/08742fd0-41a1-49d0-9698-11cb416b305f)
- [483 - 2017-01-13](https://www.keypedia.com/records/483/moores-compounding-pharmacy/1e07e177-7897-4057-8dd3-779f44cfb9b5)

## Related Officers

- [Investigator](https://www.keypedia.com/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)

Company: https://www.keypedia.com/companies/moores-compounding-pharmacy/0e6c4f61-114e-4b6c-89b8-90e301a86f6a

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