Pine Pharmaceuticals, LLC
Form 483 issued April 26, 2018 · Tonawanda, New York
- Inspection
- Apr 11 – Apr 26, 2018
- Investigator
- Rachael Moliver
- Observations
- 3
- Pages
- 3
- FEI number
- 3010943533
In short: On April 26, 2018, FDA issued a Form 483 with 3 observations to Pine Pharmaceuticals, LLC in Tonawanda, New York (FEI 3010943533) after an inspection that ran Apr 11 – Apr 26, 2018. The investigator was Rachael Moliver. Most observations concern quality system and production.
At a glance
Quality system and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Employees engaged in the processing of a drug product lack the training required to…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Strict control is not exercised over labeling issued for use in…
This inspection in context
Rachael Moliver
13 documents · 2016–2020
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 211.25(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pine Pharmaceuticals, LLC?
FDA listed 3 observations on this Form 483, mostly about quality system, production and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Pine Pharmaceuticals, LLC?
Rachael Moliver is named on this Form 483, for the inspection of Apr 11 – Apr 26, 2018. Each investigator has a profile showing what they cite most.
When was Pine Pharmaceuticals, LLC inspected by FDA?
The inspection ran Apr 11 – Apr 26, 2018, and the Form 483 is dated April 26, 2018.
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.