Morton Grove Pharmaceuticals, Inc.
Form 483 issued October 31, 2019 · Morton Grove, Illinois
- Inspection
- Aug 8 – Oct 31, 2019
- Investigators
- Linda F. Murphy· Michele L. Glendenning· Sandra A. Boyd
- Observations
- 17
- Pages
- 17
- FEI number
- 1420913
In short: On October 31, 2019, FDA issued a Form 483 with 17 observations to Morton Grove Pharmaceuticals, Inc. in Morton Grove, Illinois (FEI 1420913) after an inspection that ran Aug 8 – Oct 31, 2019. The investigators were Linda F. Murphy, Michele L. Glendenning and Sandra A. Boyd. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 11 of 17 observations.
Most cited: 21 CFR 211.160 (5×) · 211.192 (2×)
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…
- 02
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 03
Established test procedures and laboratory control mechanisms are not followed or documented at…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Linda F. Murphy
23 documents · 2015–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in India.
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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Morton Grove Pharmaceuticals, Inc.?
FDA listed 17 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Morton Grove Pharmaceuticals, Inc.?
Linda F. Murphy, Michele L. Glendenning and Sandra A. Boyd are named on this Form 483, for the inspection of Aug 8 – Oct 31, 2019. Each investigator has a profile showing what they cite most.
When was Morton Grove Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Aug 8 – Oct 31, 2019, and the Form 483 is dated October 31, 2019.
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.