Morton Grove Pharmaceuticals, Inc.
Form 483 issued March 26, 2014 · Morton Grove, Illinois
- Inspection
- Jan 22 – Mar 26, 2014
- Investigator
- Brian D. Nicholson
- Observations
- 12
- Pages
- 6
- FEI number
- 1420913
In short: On March 26, 2014, FDA issued a Form 483 with 12 observations to Morton Grove Pharmaceuticals, Inc. in Morton Grove, Illinois (FEI 1420913) after an inspection that ran Jan 22 – Mar 26, 2014. The investigator was Brian D. Nicholson. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
Laboratory records do not include a complete record of all data secured in the course ofeach…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Brian D. Nicholson
20 documents · 2013–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
The firmMorton Grove Pharmaceuticals, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Morton Grove Pharmaceuticals, Inc.?
FDA listed 12 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Morton Grove Pharmaceuticals, Inc.?
Brian D. Nicholson is named on this Form 483, for the inspection of Jan 22 – Mar 26, 2014. Each investigator has a profile showing what they cite most.
When was Morton Grove Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Jan 22 – Mar 26, 2014, and the Form 483 is dated March 26, 2014.
How do I get the full Form 483 for Morton Grove Pharmaceuticals, Inc.?
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.