Gemini Pharmaceuticals, Inc. dba Plus Pharma
Form 483 issued February 16, 2018 · Commack, New York
- Inspection
- Feb 13 – Feb 16, 2018
- Investigators
- Christopher S. Fields· Jose O. Hernandez
- Observations
- 4
- Pages
- 5
- FEI number
- 2432926
In short: On February 16, 2018, 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 Feb 13 – Feb 16, 2018. The investigators were Christopher S. Fields and Jose O. Hernandez. Most observations concern facilities & equipment and packaging & labeling.
At a glance
Facilities & equipment and packaging & labeling account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Buildings used in the manufacturing and processing of a drug product are not maintained in a…
- 02
The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient…
- 03
Written procedures for the sampling and examination of packaging and labeling materials are not followed. Your…
- 04
Written procedures are not followed for the storage, handling, sampling and testing of components and drug…
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 211.58
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 facilities & equipment, packaging & labeling and materials. The opening words of each observation are shown on this page.
Who inspected Gemini Pharmaceuticals, Inc. dba Plus Pharma?
Christopher S. Fields and Jose O. Hernandez are named on this Form 483, for the inspection of Feb 13 – Feb 16, 2018. Each investigator has a profile showing what they cite most.
When was Gemini Pharmaceuticals, Inc. dba Plus Pharma inspected by FDA?
The inspection ran Feb 13 – Feb 16, 2018, and the Form 483 is dated February 16, 2018.
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.