Morton Drug Company dba Morton LTC
Form 483 issued December 22, 2015 · Neenah, Wisconsin
- Inspection
- Dec 15 – Dec 22, 2015
- Investigators
- Ariel Cruz Figueroa· Liming Zhang
- Observations
- 7
- Pages
- 3
- FEI number
- 3008927138
In short: On December 22, 2015, FDA issued a Form 483 with 7 observations to Morton Drug Company dba Morton LTC in Neenah, Wisconsin (FEI 3008927138) after an inspection that ran Dec 15 – Dec 22, 2015. The investigators were Ariel Cruz Figueroa and Liming Zhang. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and laboratory controls account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding systems for maintaining an)' equipment used to…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
Results of stability testing are not used in determining appropriate storage…
This inspection in context
Ariel Cruz Figueroa
16 documents · 2015–2023
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmMorton Drug Company dba Morton LTC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)(vi)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Morton Drug Company dba Morton LTC?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. 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 Morton Drug Company dba Morton LTC?
Ariel Cruz Figueroa and Liming Zhang are named on this Form 483, for the inspection of Dec 15 – Dec 22, 2015. Each investigator has a profile showing what they cite most.
When was Morton Drug Company dba Morton LTC inspected by FDA?
The inspection ran Dec 15 – Dec 22, 2015, and the Form 483 is dated December 22, 2015.
How do I get the full Form 483 for Morton Drug Company dba Morton LTC?
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.