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...
Entities
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.

