Circadia by Dr Pugliese, Inc.
Form 483 issued April 1, 2022 · Leesport, Pennsylvania
- Inspection
- Mar 25 – Apr 1, 2022
- Investigator
- Michele Gottshall
- Observations
- 6
- Pages
- 3
- FEI number
- 3015538837
In short: On April 1, 2022, FDA issued a Form 483 with 6 observations to Circadia by Dr Pugliese, Inc. in Leesport, Pennsylvania (FEI 3015538837) after an inspection that ran Mar 25 – Apr 1, 2022. The investigator was Michele Gottshall. Most observations concern laboratory controls and production.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
There is no written testing program designed to assess the stability…
- 03
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 04
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
This inspection in context
Michele Gottshall
12 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmCircadia by Dr Pugliese, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Circadia by Dr Pugliese, Inc.?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Circadia by Dr Pugliese, Inc.?
Michele Gottshall is named on this Form 483, for the inspection of Mar 25 – Apr 1, 2022. Each investigator has a profile showing what they cite most.
When was Circadia by Dr Pugliese, Inc. inspected by FDA?
The inspection ran Mar 25 – Apr 1, 2022, and the Form 483 is dated April 1, 2022.
How do I get the full Form 483 for Circadia by Dr Pugliese, 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.