M Drug, LLC dba Northern Light Pharmacy
Amended 483 issued July 19, 2019 · Bangor, Maine
- Inspection
- Jul 16 – Jul 19, 2019
- Investigator
- Edmund F. Mrak
- Observations
- 3
- Pages
- 4
- FEI number
- 3002159099
In short: On July 19, 2019, FDA issued a Amended 483 with 3 observations to M Drug, LLC dba Northern Light Pharmacy in Bangor, Maine (FEI 3002159099) after an inspection that ran Jul 16 – Jul 19, 2019. The investigator was Edmund F. Mrak. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Observations span 1 system, led by facilities & equipment.
Most cited: FDCA 501(a)(2)(A) (2×) · 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01FDCA 501(a)(2)(A)
You produced hazardous diugs without providing adequate containment, segregation, cleaning of work surfaces and cleaning of…
- 02FDCA 501(a)(2)(A)
Your facility design allowed the influx of poor quality air into…
- 03
Your Firm released drug product in which the strength differs from, or its purity or quality…
The full amended 483
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Edmund F. Mrak
30 documents · 2010–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmM Drug, LLC dba Northern Light Pharmacy history
The site's inspection history, in date order.
Similar documentsOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at M Drug, LLC dba Northern Light Pharmacy?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected M Drug, LLC dba Northern Light Pharmacy?
Edmund F. Mrak is named on this Amended 483, for the inspection of Jul 16 – Jul 19, 2019. Each investigator has a profile showing what they cite most.
When was M Drug, LLC dba Northern Light Pharmacy inspected by FDA?
The inspection ran Jul 16 – Jul 19, 2019, and the Amended 483 is dated July 19, 2019.
How do I get the full Amended 483 for M Drug, LLC dba Northern Light Pharmacy?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.