Norwich Pharmaceuticals, Inc.
Form 483 issued March 16, 2021 · Norwich, New York
- Inspection
- Mar 8 – Mar 16, 2021
- Investigator
- Mindy M. Chou
- Observations
- 2
- Pages
- 2
- FEI number
- 1350044
In short: On March 16, 2021, FDA issued a Form 483 with 2 observations to Norwich Pharmaceuticals, Inc. in Norwich, New York (FEI 1350044) after an inspection that ran Mar 8 – Mar 16, 2021. The investigator was Mindy M. Chou. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×) · 211.63 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Mindy M. Chou
37 documents · 2015–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New York.
The firmNorwich Pharmaceuticals, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Norwich Pharmaceuticals, Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Norwich Pharmaceuticals, Inc.?
Mindy M. Chou is named on this Form 483, for the inspection of Mar 8 – Mar 16, 2021. Each investigator has a profile showing what they cite most.
When was Norwich Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Mar 8 – Mar 16, 2021, and the Form 483 is dated March 16, 2021.
How do I get the full Form 483 for Norwich 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.