Gemini Pharmaceuticals, Inc. dba Plus Pharma
Form 483 issued June 1, 2011 · Commack, New York
- Inspection
- May 25 – Jun 1, 2011
- Investigator
- Alice S. Tsao
- Observations
- 2
- Pages
- 2
- FEI number
- 2432926
In short: On June 1, 2011, FDA issued a Form 483 with 2 observations to Gemini Pharmaceuticals, Inc. dba Plus Pharma in Commack, New York (FEI 2432926) after an inspection that ran May 25 – Jun 1, 2011. The investigator was Alice S. Tsao. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.110(a) (1×) · 211.166(a)(2) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
The written stability program for drug products does not describe the storage conditions for…
This inspection in context
Alice S. Tsao
16 documents · 2011–2023
Cites 211.67 (equipment cleaning and maintenance) 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 211.110(a)
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 2 observations on this Form 483, mostly about production and laboratory controls. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Gemini Pharmaceuticals, Inc. dba Plus Pharma?
Alice S. Tsao is named on this Form 483, for the inspection of May 25 – Jun 1, 2011. Each investigator has a profile showing what they cite most.
When was Gemini Pharmaceuticals, Inc. dba Plus Pharma inspected by FDA?
The inspection ran May 25 – Jun 1, 2011, and the Form 483 is dated June 1, 2011.
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.