# FDA 483 - MOORE'S PHARMACY INC - September 01, 2016

Source: https://www.keypedia.com/records/483/moores-pharmacy-inc/71aaa2f2-04a8-43fd-8803-77455bd917a5

> FDA 483 for MOORE'S PHARMACY INC on September 01, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MOORE'S PHARMACY INC
- Inspection Date: 2016-09-01
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: The FDA Form 483 details significant deficiencies at a drug manufacturing facility. The building itself was not maintained in a clean and sanitary condition, with a large dead cockroach observed in the drug production room, and both live and dead pests in the pharmacy where capsules are stored. Structural issues included a 1x1 foot hole in the roof of the production room exposing insulation and an uncontrolled warehouse, and gaps of 1 inch and 0.5 inches under production room doors, allowing pest entry.

The firm failed to conduct potency testing of non-sterile finished products, despite routinely assigning 180-day Beyond Use Dates (BUDs). From 7/25/2015 to 7/13/2016, no finished products were sent for testing. In-process control procedures were deficient, lacking examination of mixing adequacy for uniformity and homogeneity, particularly for progesterone-containing capsules. Formula worksheets did not clearly indicate how pharmacists could verify correct mixing.

Finished product testing from 12/17/2014 to 8/26/2016 showed 70% of tested lots had out-of-specification potency results (sub- or super-potent), with examples including Estrone at 134% and Estriol at 56.7% of expected levels. No investigations, CAPAs, or recalls were performed for these failures, and customers were not notified of issues with sub

## Related Documents

- [WARNING_LETTER - 2016-09-01](https://www.keypedia.com/records/warning_letter/moores-pharmacy-inc/c935605f-8985-478f-8313-79385eccf44a)

## Related Officers

- [Development Coordinator](https://www.keypedia.com/people/shawn-e-larson/a3515e47-60a3-48ff-b27c-f79bd03db12b)

Company: https://www.keypedia.com/companies/moores-pharmacy-inc/5c09e78c-1eb6-42fe-ae78-0c4df7df0ad3

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