Pine Pharmaceuticals, LLC
Form 483 issued May 14, 2021 · Tonawanda, New York
- Inspection
- May 3 – May 14, 2021
- Investigators
- Johnna L. Bleem· Mindy M. Chou
- Observations
- 5
- Pages
- 7
- FEI number
- 3010943533
In short: On May 14, 2021, FDA issued a Form 483 with 5 observations to Pine Pharmaceuticals, LLC in Tonawanda, New York (FEI 3010943533) after an inspection that ran May 3 – May 14, 2021. The investigators were Johnna L. Bleem and Mindy M. Chou. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Procedures designed to prevent microbiological contaminat ion of drug products purporting to be sterile are not…
- 03
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
This inspection in context
Johnna L. Bleem
6 documents · 2019–2021
Cites 211.67 (equipment cleaning and maintenance) 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, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Pine Pharmaceuticals, LLC?
Johnna L. Bleem and Mindy M. Chou are named on this Form 483, for the inspection of May 3 – May 14, 2021. Each investigator has a profile showing what they cite most.
When was Pine Pharmaceuticals, LLC inspected by FDA?
The inspection ran May 3 – May 14, 2021, and the Form 483 is dated May 14, 2021.
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.