Morton Grove Pharmaceuticals, Inc.
Form 483 issued May 20, 2021 · Morton Grove, Illinois
- Inspection
- Apr 19 – May 20, 2021
- Investigators
- Arsen Karapetyan· Justin A. Boyd· Nibin Varghese
- Observations
- 12
- Pages
- 22
- FEI number
- 1420913
In short: On May 20, 2021, FDA issued a Form 483 with 12 observations to Morton Grove Pharmaceuticals, Inc. in Morton Grove, Illinois (FEI 1420913) after an inspection that ran Apr 19 – May 20, 2021. The investigators were Arsen Karapetyan, Justin A. Boyd, Nibin Varghese and Sarah E. Rhoades. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 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
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Procedures describing the handling of written and oral complaints related to ding products are…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) 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 211.192
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 facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Morton Grove Pharmaceuticals, Inc.?
Arsen Karapetyan, Justin A. Boyd, Nibin Varghese and Sarah E. Rhoades are named on this Form 483, for the inspection of Apr 19 – May 20, 2021. Each investigator has a profile showing what they cite most.
When was Morton Grove Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Apr 19 – May 20, 2021, and the Form 483 is dated May 20, 2021.
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.