Maag Prescription Center LLC
Form 483 issued September 28, 2018 · Pocatello, Idaho
- Inspection
- Sep 28, 2018
- Investigator
- Tracy K. Li
- Observations
- 5
- Pages
- 4
- FEI number
- 3014481174
In short: On September 28, 2018, FDA issued a Form 483 with 5 observations to Maag Prescription Center LLC in Pocatello, Idaho (FEI 3014481174) after an inspection that ran Sep 28, 2018. The investigator was Tracy K. Li. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firn used non-pharmaceutical grade components that are not intended for drug production in the formulation…
- 02
Your firm produced hazardous drugs without providing adequate containment, segregation, cleaning of work surfaces, and cleaning…
- 03
Your firm lacks proper control to prevent contamination of…
- 04
Mixing tools used in the production of drug products is not of appropriate design to facilitate…
This inspection in context
Tracy K. Li
11 documents · 2015–2018
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Idaho.
The firmMaag Prescription Center LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Maag Prescription Center LLC?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Maag Prescription Center LLC?
Tracy K. Li is named on this Form 483, for the inspection of Sep 28, 2018. Each investigator has a profile showing what they cite most.
When was Maag Prescription Center LLC inspected by FDA?
The inspection ran Sep 28, 2018, and the Form 483 is dated September 28, 2018.
How do I get the full Form 483 for Maag Prescription Center LLC?
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.