Key facts
| Firm | Pine Pharmaceuticals LLC |
|---|---|
| FEI / inspection ID | 3010943533 |
| Inspection end date | November 14, 2025 |
| Citation count | 2 |
What a Form 483 means
A Form FDA 483 is issued at the close of an FDA facility inspection to list conditions an investigator observed that may violate the Federal Food, Drug, and Cosmetic Act or its implementing regulations. It reflects the investigator's professional judgment at that point in time and is not a final agency determination, an enforcement action, or proof that a violation occurred. Firms are expected to respond in writing, typically within 15 business days, describing the corrective and preventive actions they plan to take. FDA reviews that response, along with any follow-up evidence, before deciding what happens next. Many 483s are resolved through corrective action alone. When FDA judges a firm's response inadequate, or when the underlying conditions are serious enough, the observations documented here can lead to a Warning Letter or further regulatory action. This page presents the observations exactly as recorded on the FDA-issued document; always confirm citation language against the original record before relying on it.
Citations explained
Observation 1 — Procedures designed to prevent microbiological contamination of drug products purporting to be
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 ofBevacizurnab l.25 mg/0 .05 mL injection, batch 84058 , we observed your operator re sting their arms on the ergonomic support bars outside the I SO =i area and then extending their arms and sleeves into the I SO r.l critical zone during the aseptic processing without sanitizing their sleeves, as required by SOP-229 , "Cleanroom Beh avior and Aseptic Technique," Rev. 04 . 2) During video review on 11112/ 2025, we observed poor aseptic technique by your operator during the produc tion of Calcium CL 20 mg/rnL (500 mL) inj , lot 83663 , e xp 04/ 04 / 2026 , produced on (b) (4) . For example, ---n,q J.:lf/'I OArEtSWFO SEE REVERSE L gan T Williams, Investig ator 11/14/2025 Anna M Spiros, Inve stigator t\- ~OfTHIS PAGE ----- Jordan S Burkdoll,.
Observation 2 — Employees engaged m the processing of a drug product lack the training
Employees engaged m the processing of a drug product lack the training required co perfonn their assigned functions. Specifically. Your manual visual 111specuon personnel are not adequately qualified. Your firm implemented changes to your SOP-155, "Trammg and Qualification of Qualified Visual Inspectors for Compounded > Product�". Revision 9, for visual m.spe,t1on qualification which included(D)(4) after '!bH4 (b)(4) . Your finn failed to retroactively review your inspectors' previous qual1ficat1ons to ,, r�IGIATI.t<S g_,--pp 0rii'fl�£0 SEE REVERSE Logan r Williams, Inve¥t1gator 11/14/2025 OF THIS PAGE .l.nna H Sf1tos, In.,estigator � Jordan S Burkdoll, J nv,.:s • 1-ga tor x® ,Ol,'f fl),\ �1 ...111 . ,uvn., mrrxam=ni l'.ViP(M'IO!lo.U Oll!i[l\ .A TIONi; , '
Pine Pharmaceuticals LLC’s FDA history
Argus HQ has recorded 1 total FDA action tied to Pine Pharmaceuticals LLC: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- What is an FDA Form 483?
- A Form FDA 483 lists an FDA investigator's written observations at the close of a facility inspection, issued under section 704(b) of the Federal Food, Drug, and Cosmetic Act. It documents conditions the investigator judged may violate FDA regulations. A 483 is not an enforcement action or a final determination that a violation occurred.
- Does this Form 483 mean Pine Pharmaceuticals LLC violated the law?
- No. A Form 483 documents an investigator's observations only. FDA reviews the firm's written response and any corrective actions taken before deciding whether further action is warranted, and many 483s are closed without additional enforcement once a firm shows adequate correction.
- What happens after a Form 483 is issued?
- The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.
- Has Pine Pharmaceuticals LLC had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for Pine Pharmaceuticals LLC so far. Argus ingests new FDA records daily.
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Related enforcement actions
Full FDA history for Pine Pharmaceuticals LLCCompiled 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.
Argus HQ Research (2025). FDA Inspects Pine Pharmaceuticals LLC: Form 483 with 2 Citations (November 14, 2025). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-pine-pharmaceuticals-llc-2025-11-14-3010943533
"FDA Inspects Pine Pharmaceuticals LLC: Form 483 with 2 Citations (November 14, 2025)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-pine-pharmaceuticals-llc-2025-11-14-3010943533.
Argus HQ Research. "FDA Inspects Pine Pharmaceuticals LLC: Form 483 with 2 Citations (November 14, 2025)." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-pine-pharmaceuticals-llc-2025-11-14-3010943533.
@misc{argushq_argushq_ai_483_fda_483_pine_pharmaceuticals_llc_2025_11_14_3010943533_2025,
title = {FDA Inspects Pine Pharmaceuticals LLC: Form 483 with 2 Citations (November 14, 2025)},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-pine-pharmaceuticals-llc-2025-11-14-3010943533},
note = {Accessed: July 15, 2026}
}