Pine Pharmaceuticals, LLC
Form 483 issued October 23, 2015 · Tonawanda, New York
- Inspection
- Oct 5 – Oct 9, 2015
- Investigators
- James A. Liubicich· Mindy M. Chou
- Observations
- 5
- Pages
- 3
- FEI number
- 3010943533
In short: On October 23, 2015, FDA issued a Form 483 with 5 observations to Pine Pharmaceuticals, LLC in Tonawanda, New York (FEI 3010943533) after an inspection that ran Oct 5 – Oct 9, 2015. The investigators were James A. Liubicich and Mindy M. Chou. Most observations concern quality system and facilities & equipment.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 03
For each batch of drug product, there shall be appropriate laboratory determination of satisfactory conformance to…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
James A. Liubicich
13 documents · 2013–2015
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmPine Pharmaceuticals, LLC history
All 8 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pine Pharmaceuticals, LLC?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Pine Pharmaceuticals, LLC?
James A. Liubicich and Mindy M. Chou are named on this Form 483, for the inspection of Oct 5 – Oct 9, 2015. Each investigator has a profile showing what they cite most.
When was Pine Pharmaceuticals, LLC inspected by FDA?
The inspection ran Oct 5 – Oct 9, 2015, and the Form 483 is dated October 23, 2015.
How do I get the full Form 483 for Pine Pharmaceuticals, LLC?
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.