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fda_483 · inspection_citation · high

Pine Pharmaceuticals LLC -- FDA 483: 2 observations (2025-11-14)

Event date
2025-11-14 00:00:00Z
Observed
2026-07-12 22:31:32Z
Source ID
3010943533-2025-11-14-190690
Payload hash
be6fbd8a1f41c84ee6903dd9…

Summary

Observation 2: Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed. Specificall y, 1 ) On 11 /4/2025, during the aseptic repackaging...

Frequently asked questions

Has Pine Pharmaceuticals LLC had other FDA enforcement actions?
Yes. Argus HQ has recorded 2 total FDA actions tied to Pine Pharmaceuticals LLC: 1 warning letter, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
What kind of FDA record is this?
This is an Argus HQ record of a FDA Form 483 Inspection Observation, tagged high severity by Argus HQ. FDA published the underlying record on 2025-11-14; Argus observed and indexed it on 2026-07-12.
Where can I verify this record directly with FDA?
The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA
Argus HQ Research (2025). Pine Pharmaceuticals LLC -- FDA 483: 2 observations (2025-11-14). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-483-pine-pharmaceuticals-llc-2025-11-14-3010943533
MLA
"Pine Pharmaceuticals LLC -- FDA 483: 2 observations (2025-11-14)." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/events/fda-483-pine-pharmaceuticals-llc-2025-11-14-3010943533.
Chicago
Argus HQ Research. "Pine Pharmaceuticals LLC -- FDA 483: 2 observations (2025-11-14)." Digital Empire Holdings LLC. Accessed October 7, 2026. https://argushq.ai/events/fda-483-pine-pharmaceuticals-llc-2025-11-14-3010943533.
BibTeX
@misc{argushq_argushq_ai_events_fda_483_pine_pharmaceuticals_llc_2025_11_14_3010943533_2025,
  title = {Pine Pharmaceuticals LLC -- FDA 483: 2 observations (2025-11-14)},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-483-pine-pharmaceuticals-llc-2025-11-14-3010943533},
  note = {Accessed: October 7, 2026}
}

Informational only. Not legal, financial, or medical advice.