Montana Compounding Phatmacy P.C
Form 483 issued August 30, 2016 · Missoula, Montana
- Inspection
- Aug 30, 2016
- Investigators
- Farhana Khan· Tracy K. Li
- Observations
- 5
- Pages
- 3
- FEI number
- 3011412185
In short: On August 30, 2016, FDA issued a Form 483 with 5 observations to Montana Compounding Phatmacy P.C in Missoula, Montana (FEI 3011412185) after an inspection that ran Aug 30, 2016. The investigators were Farhana Khan and Tracy K. Li. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
4 of 5 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Non-pharmaceutical grade components are used in the formulation…
- 02
Vermin was observed in…
- 03
Non-microbial contamination was observed…
- 04
Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or…
This inspection in context
Farhana Khan
7 documents · 2016–2021
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmMontana Compounding Phatmacy P.C history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Montana Compounding Phatmacy P.C?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment and materials. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Montana Compounding Phatmacy P.C?
Farhana Khan and Tracy K. Li are named on this Form 483, for the inspection of Aug 30, 2016. Each investigator has a profile showing what they cite most.
When was Montana Compounding Phatmacy P.C inspected by FDA?
The inspection ran Aug 30, 2016, and the Form 483 is dated August 30, 2016.
How do I get the full Form 483 for Montana Compounding Phatmacy P.C?
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.