# FDA 483 - M Drug, LLC dba Northern Light Pharmacy - July 19, 2019

Source: https://www.keypedia.com/records/483/m-drug-llc-dba-northern-light-pharmacy/928c3e11-52fe-4fcf-9b3a-0a6c88fb0790

> FDA 483 for M Drug, LLC dba Northern Light Pharmacy on July 19, 2019. Product: N/A. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: M Drug, LLC dba Northern Light Pharmacy
- Inspection Date: 2019-07-19
- Office Name: New England District Office
- Summary: This FDA Form 483 details observations from an inspection of M Drug, LLC dba Northern Light Pharmacy, a producer of drug products, located at 210 State St, Bangor, ME, conducted from July 16-19, 2019. Lucas J. Bayne, Pharmacist in Charge, was the individual to whom the report was issued.

**Observation 1** notes the production of hazardous drugs, specifically Tacrolimus, without adequate containment, segregation, or cleaning to prevent cross-contamination. Deficiencies include no designed airflow control or engineered containment for open processing, exposed non-dedicated compounding equipment, inadequate cleaning methods for non-dedicated utensils and work surfaces to remove drug residues, and no designed airflow direction or pressure differential between the compounding room and adjacent areas to contain hazardous substances.

**Observation 2** identifies facility design issues allowing poor quality air into a higher classified area. The compounding facility lacks adequate control of microorganisms and particulates. Specific issues include a window-mounted air conditioner with visible particulate residues and gaps, no pre-filtration of intake air, personnel not required to wear hair covers, a chipped shelf, and product contact utensils with wood handles, all making cleaning challenging.

**Observation 3** states the firm released drug product where the strength, purity, or quality was deficient. This includes a lack of data to show the electronic balance used for weighing active pharmaceutical ingredients (APIs) provides accurate and repeatable results. The balance

## Related Documents

- [STATE_REFERRAL_LETTER - 2019-07-17](https://www.keypedia.com/records/state_referral_letter/m-drug-llc-dba-northern-light-pharmacy/375c3c17-88f9-4d85-92ea-a922bcbefd90)

## Related Officers

- [Investigator](https://www.keypedia.com/people/edmund-f-mrak/a43cf86a-c020-4948-bff6-358b2453908a)

Company: https://www.keypedia.com/companies/m-drug-llc-dba-northern-light-pharmacy/87eb149c-5553-4ff5-985f-25e8fdc2a2fb

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144