Morton Drug Company dba Morton LTC
Form 483 issued August 31, 2018 · Neenah, Wisconsin
- Inspection
- Aug 27 – Aug 31, 2018
- Investigators
- Sandra A. Hughes· Tenzin Jangchup
- Observations
- 3
- Pages
- 2
- FEI number
- 3008927138
In short: On August 31, 2018, FDA issued a Form 483 with 3 observations to Morton Drug Company dba Morton LTC in Neenah, Wisconsin (FEI 3008927138) after an inspection that ran Aug 27 – Aug 31, 2018. The investigators were Sandra A. Hughes and Tenzin Jangchup. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 3 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×) · 211.56 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You produced beta-lactam drugs without providing adequate cleaning of work surfaces…
- 02
Materials or supplies were not disinfected prior to entering…
- 03
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities…
This inspection in context
Sandra A. Hughes
23 documents · 2009–2019
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Wisconsin.
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 211.113
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 3 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Morton Drug Company dba Morton LTC?
Sandra A. Hughes and Tenzin Jangchup are named on this Form 483, for the inspection of Aug 27 – Aug 31, 2018. Each investigator has a profile showing what they cite most.
When was Morton Drug Company dba Morton LTC inspected by FDA?
The inspection ran Aug 27 – Aug 31, 2018, and the Form 483 is dated August 31, 2018.
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.