Gemini Pharmaceuticals, Inc. dba Plus Pharma
Form 483 issued July 26, 2022 · Commack, New York
- Inspection
- Jul 21 – Jul 26, 2022
- Investigator
- Christopher S. Fields
- Observations
- 1
- Pages
- 2
- FEI number
- 2432926
In short: On July 26, 2022, FDA issued a Form 483 with 1 observation to Gemini Pharmaceuticals, Inc. dba Plus Pharma in Commack, New York (FEI 2432926) after an inspection that ran Jul 21 – Jul 26, 2022. The investigator was Christopher S. Fields. Most observations concern dietary supplement CGMP; the most-cited regulation is 21 CFR 111.75 (what must you do to determine whether specifications are met?).
At a glance
1 of 1 observations on this 483 concern dietary supplement cgmp.
Most cited: 21 CFR 111.75(c) (1×)
What FDA observed
Preview: the opening words of each observation- 01
You did not verify that your finished batch of dietary supplement meets product specifications for identity…
This inspection in context
Christopher S. Fields
2 documents · 2018–2022
Cites 111.75(c) (what must you do to determine whether specifications are met?) more than any other section. Most of their documents are for sites in New York.
The firmGemini Pharmaceuticals, Inc. dba Plus Pharma history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 111.75(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Gemini Pharmaceuticals, Inc. dba Plus Pharma?
FDA listed 1 observation on this Form 483, mostly about dietary supplement CGMP. The most-cited regulation is 21 CFR 111.75 (what must you do to determine whether specifications are met?). The opening words of each observation are shown on this page.
Who inspected Gemini Pharmaceuticals, Inc. dba Plus Pharma?
Christopher S. Fields is named on this Form 483, for the inspection of Jul 21 – Jul 26, 2022. Each investigator has a profile showing what they cite most.
When was Gemini Pharmaceuticals, Inc. dba Plus Pharma inspected by FDA?
The inspection ran Jul 21 – Jul 26, 2022, and the Form 483 is dated July 26, 2022.
How do I get the full Form 483 for Gemini Pharmaceuticals, Inc. dba Plus Pharma?
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.