# FDA 483 - Montana Compounding Pharmacy P.C. - September 22, 2021

Source: https://www.keypedia.com/records/483/montana-compounding-pharmacy-pc/eef7dd20-30a5-4b54-828a-c58434c369ea

> FDA 483 for Montana Compounding Pharmacy P.C. 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 P.C.
- Inspection Date: 2021-09-22
- Product Type: Drugs
- Office Name: Seattle District Office
- Summary: This FDA Form 483 documents observations from an inspection of a facility producing non-sterile drug products. The facility produced over (b)(4) non-sterile drug products in an approximately (b)(4) period, from (b)(4) to (b)(4). This included over (b)(4) highly potent drugs like testosterone, progesterone, and estrogen (e.g., RX# (b)(6) Bi-Est (8:2) - Progesterone - Testosterone 5 - 60 - 2.25 mg/gm (b)(4)), and over (b)(4) hazardous drugs such as Triodo-L-Thyronine (T3) and Thyroxine(L) (T4) (e.g., RX# (b)(6) Liothyronine Sodium (T3) 1:1000 (0.1%) (b)(4)).

The primary observation is the inadequate containment, segregation, and cleaning practices to prevent cross-contamination from highly potent and hazardous drugs. Specifically:
a) The firm lacks controls, such as dedicated or segregated areas, to prevent contamination of the drug production area and cross-contamination of other drug products with highly potent and hazardous drugs. All non-sterile drugs are compounded using (b)(4) work benches, which do not adequately contain the (b)(4) bulk drug substances.
b) The firm does not replace gowns between producing

## Related Documents

- [483 - 2016-09-20](https://www.keypedia.com/records/483/montana-compounding-pharmacy-pc/46e4b1da-18b6-44dc-a083-dedf9357bd5d)

## Related Officers

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

Company: https://www.keypedia.com/companies/montana-compounding-pharmacy-pc/ddab0085-0978-43e9-8bb4-bd5a740678eb

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913