Gemini Pharmaceuticals, Inc. dba Plus Pharma
Form 483 issued June 30, 2015 · Commack, New York
- Inspection
- Jun 23 – Jun 30, 2015
- Investigators
- Charisse K. Green· Deborah J. Parris
- Observations
- 4
- Pages
- 2
- FEI number
- 2432926
In short: On June 30, 2015, FDA issued a Form 483 with 4 observations to Gemini Pharmaceuticals, Inc. dba Plus Pharma in Commack, New York (FEI 2432926) after an inspection that ran Jun 23 – Jun 30, 2015. The investigators were Charisse K. Green and Deborah J. Parris. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
- 03
Batch production and control records do not include the identification of the persons performing each significant…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
This inspection in context
Charisse K. Green
5 documents · 2005–2015
Cites 123.6 (hazard analysis and hazard analysis critical control point (haccp) plan) 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 211.63
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 4 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Gemini Pharmaceuticals, Inc. dba Plus Pharma?
Charisse K. Green and Deborah J. Parris are named on this Form 483, for the inspection of Jun 23 – Jun 30, 2015. Each investigator has a profile showing what they cite most.
When was Gemini Pharmaceuticals, Inc. dba Plus Pharma inspected by FDA?
The inspection ran Jun 23 – Jun 30, 2015, and the Form 483 is dated June 30, 2015.
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.