Where can I read the full Form 483?

The verbatim inspection record is the source of truth — always confirm citation language against the original FDA document before acting.

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 US Specialty Formulations 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.

January 14, 2026 FDA Form 483 for US Specialty Formulations LLC

Key facts

Firm	US Specialty Formulations LLC
FEI / inspection ID	3010680515
Inspection end date	January 14, 2026
Citation count	5

The short version: FDA inspected US Specialty Formulations LLC in Pennsylvania and issued a Form 483 listing 5 inspectional observations following an inspection that concluded 2026-01-14. FDA records classify US Specialty Formulations LLC as a outsourcing facility. A Form 483 documents an investigator's findings at the close of an inspection under the Federal Food, Drug, and Cosmetic Act; it is not a final agency compliance determination. The observations on this page are drawn directly from the FDA-issued Form 483 record.

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 — Th e r es ponsibilities and procedures applicable t o th e

Th e r es ponsibilities and procedures applicable t o th e q uality cont rol un it are not f ully followe d. Spec ifically, (A) Your firm has not established scientifically sound and appropriate specifications for finished drug product identity, pH, assay, and impurity specifications to ver ify the labeled strength of 0.17 g/m L for Sarracenia Purpurea 0. 17 g/mL for Injection, nor has it conducted the requ ir ed testing pr i or to release. From June 1, 2024, to January 5, 2026, Tr• lots of Sarracenia Purpurea 0.17 g/m L for Injection were released and distributed to the U.S. market without assay and impurities testing, totaling approximately[( t:5) (4~ vials, and two finished products lots (Lot# 02RS1502A and# 02RS 1507A) were not tested for pH. pH testing was not performed for the lots produced pr i or to 2025. (B) Your quality unit failed to ensure that potency and impur ity testing of your in-house.

Observation 2 — Th e accu racy, sensitivi t y, speci fi city an d

Th e accu racy, sensitivi t y, speci fi city an d rep roduci bili ty of t est methods have not been estab lished and docu mented. Spec ifically, (A) You have not established stability-indicating test methods to determine the stability of Sarracenia Purpurea 0. 17 g/mL for Injection, and the current analytical methods lack the capability to identify potential degradants and impurities in the finished drug product. (B) You have not demonstrated that your in-house benzyl alcohol test method QC-0060, Assay of Benzyl Alcohol, for testing incoming material is equal to or better than the USP compendia! method. Benzyl alcohol is the preservative in Sarracenia Purpurea 0.17 g/mL for In jection . (C) Method validation has not been pe rformed for QC-0060, Assay of Benzyl Alcohol. This method is utilized for benzyl alcohol raw mater ia l release testing as well as re lease and stability testing of Sarracenia Pu rpurea Bulk Distillate and Sarracenia Purpur ea 0..

Observation 3 — There is no w ri tte n testing pr ogram de si

There is no w ri tte n testing pr ogram de si gned to a ss ess the stab ility character is ti cs of dr ug produ ct s. Spec ifically, (A) You do not have adequate stability data from a scientifically sound stability program to support the la beled 12-month product expiry date for Sarracenia Pur purea 0 .1 7 g/m L for Injection. In addition, the finished product expiration date is calculated from the filling date rather than the bulk manufacturi ng date, and the stability program design does not account for the age of the bulk material at the time of filling. Sarracenia Purpurea Bulk Distillate Lot 6 4 (manufactured 6 4 ; retest date 6 4 ) was used to fill two lots of Sarracenia Purpurea 0.17 g/mL for Inj ection with different expiration dates: Lot #02RT1 501A filled on February 21, 2025 (Exp. 02/28/2026) and Lot #02RT1 502A fill ed on May 16, 2025.

Observation 4 — Procedures de si gned to prev ent microbiologi ca l contami nation

Procedures de si gned to prev ent microbiologi ca l contami nation of drug produ ct s purporting to be sterile are not established and fo llow ed. Spec ifically, EMPLOYE E($) SIGNATURE DATE lSSUEO SEE REVERSE Mi n dy M Ch o u, I n ve s ti g at o r 1 / 1 4 /2026 OF THIS PAGE Lu Che n , I n ve s ti g at o r cnou 2000648922 ~ SIQ'lecl ' : 0 1•14+202.6 X 11:2r-.J1

Observation 5 — Drug products are not stored under appropriate conditions of temperature so t

Drug products are not stored under appropriate conditions of temperature so t hat their identity, st re ngth, qua li ty, and pu rity a re not affected. Spec ifically, Sar race n ia Purpurea Bu lk Dis tillate bags used in the production of Sarracenia Pu rpurea 0.17 g/ml for Injection are stored inf~ ] with no te mperature monito ring of the area. *DATES OF INSPECTION 1/05/2026(Mo n), 1/06/2026(Tue ), 1/07 /2026(Wed), 1/08/2026(Thu), 1/09/2026( Fr i), 1/12/2026(Mo n), 1/13/2026(Tu e), 1/14/2026(Wed) Lu Chen =~2003284605 X Date Signed: 0 1-14--2026 11 :28:07 SEE REVERSE OF THIS PAGE EMPLOY EE($) SIGNATURE Min dy M Chou, I nves ti ga t or Lu Chen, I nves ti ga t or DATE lSSUEO 1 / 1 4/2026

US Specialty Formulations LLC’s FDA history

Argus HQ has recorded 1 total FDA action tied to US Specialty Formulations LLC: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

Where can I read the full Form 483?: The verbatim inspection record is the source of truth — always confirm citation language against the original FDA document before acting.
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 US Specialty Formulations 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.

See if this 483 escalates to a warning letter — before your auditor asks.

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Full FDA history for US Specialty Formulations LLC

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 (2026). January 14, 2026 FDA Form 483 for US Specialty Formulations LLC — 5 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-us-specialty-formulations-llc-2026-01-14-3010680515

MLA

"January 14, 2026 FDA Form 483 for US Specialty Formulations LLC — 5 Citations." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/483/fda-483-us-specialty-formulations-llc-2026-01-14-3010680515.

Chicago

Argus HQ Research. "January 14, 2026 FDA Form 483 for US Specialty Formulations LLC — 5 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-us-specialty-formulations-llc-2026-01-14-3010680515.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_us_specialty_formulations_llc_2026_01_14_3010680515_2026,
  title = {January 14, 2026 FDA Form 483 for US Specialty Formulations LLC — 5 Citations},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-us-specialty-formulations-llc-2026-01-14-3010680515},
  note = {Accessed: July 15, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗