# FDA 483 - Montana Compounding Pharmacy PC - September 22, 2021

Source: https://www.globalkeysolutions.net/records/483/montana-compounding-pharmacy-pc/75e315f6-b6fc-4905-95eb-c4eebf6370a6

> FDA 483 for Montana Compounding Pharmacy PC on September 22, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Montana Compounding Pharmacy PC
- Inspection Date: 2021-09-22
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Montana Compounding Pharmacy P.C. in Missoula, MT, revealed a repeat observation concerning the production of non-sterile drug products. The firm failed to provide adequate containment, segregation, and cleaning practices to prevent cross-contamination of highly potent and hazardous drugs. This deficiency poses a significant risk to product quality and patient safety.

## Related Documents

- [WARNING_LETTER - 2015-05-08](https://www.globalkeysolutions.net/records/warning_letter/montana-compounding-pharmacy-pc/89518b8b-784a-47c4-a3b9-a85c3f4a222b)
- [483 - 2015-05-08](https://www.globalkeysolutions.net/records/483/montana-compounding-pharmacy-pc/38f98f6e-c0fe-42f3-b11b-fe96401554e3)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/sangeeta-m-khurana/bed4533f-a9aa-47c5-9e0b-f20ad36461aa)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/kenneth-o-gee/d61312c0-1422-4487-a5d6-ec6e76d242ee)

Company: https://www.globalkeysolutions.net/companies/montana-compounding-pharmacy-pc/6c21cdc3-ef08-46ab-8725-6cbabc6383b8

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822