Pine Pharmaceuticals, LLC
Form 483 issued September 19, 2023 · Tonawanda, New York
- Inspection
- Sep 6 – Sep 19, 2023
- Investigator
- Tekalign Wondimu
- Observations
- 7
- Pages
- 7
- FEI number
- 3010943533
In short: On September 19, 2023, FDA issued a Form 483 with 7 observations to Pine Pharmaceuticals, LLC in Tonawanda, New York (FEI 3010943533) after an inspection that ran Sep 6 – Sep 19, 2023. The investigator was Tekalign Wondimu. Most observations concern quality system and production.
At a glance
Observations span 2 systems, led by quality system.
Most cited: FDCA 501(a)(2)(A) (3×)
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks the responsibility and authority to approve and reject all in process…
- 02
There is a failure to thoroughly review the failure of a batch or any of its…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04FDCA 501(a)(2)(A)
Personnel were observed conducting aseptic manipulations where the movement of "first air" in the ISO 5…
This inspection in context
Tekalign Wondimu
12 documents · 2021–2026
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Virginia.
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 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pine Pharmaceuticals, LLC?
FDA listed 7 observations on this Form 483, mostly about quality system and production. The opening words of each observation are shown on this page.
Who inspected Pine Pharmaceuticals, LLC?
Tekalign Wondimu is named on this Form 483, for the inspection of Sep 6 – Sep 19, 2023. Each investigator has a profile showing what they cite most.
When was Pine Pharmaceuticals, LLC inspected by FDA?
The inspection ran Sep 6 – Sep 19, 2023, and the Form 483 is dated September 19, 2023.
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.