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 Cascade Specialty Pharmacy LLC had other FDA inspection citations?

This is the only FDA action Argus HQ has on file for Cascade Specialty Pharmacy LLC so far. Argus ingests new FDA records daily.

What is the FEI / inspection ID for this Form 483?

FEI / inspection ID: 3015133983.

Is a Form 483 the same as a Warning Letter?

No. A Form 483 lists an FDA investigator’s observations at the close of an inspection; it is not a final agency determination. FDA may or may not follow up with a Warning Letter depending on the firm’s response and the severity of the findings.

July 17, 2026 FDA Form 483 for Cascade Specialty Pharmacy LLC

Key facts

Firm	Cascade Specialty Pharmacy LLC
FEI / inspection ID	3015133983
Inspection end date	July 17, 2026
Citation count	6

Key takeaway: FDA inspected Cascade Specialty Pharmacy LLC in Washington and issued a Form 483 listing 6 inspectional observations following an inspection that concluded 2026-07-17. FDA records classify Cascade Specialty Pharmacy LLC as a producer of non sterile drug products. 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.

Citations explained

Observation 1 — The responsibilities and procedures applicable to the quality control unit are not fully

The responsibilities and procedures applicable to the quality control unit are not fully followed. Specifically, Your firm's written procedure designates the pharmacist as responsible for ensuring the accuracy of compounding records and perfonning quality checks requiring pharmacist verification. However, your firm's compounding record does not specify container and closure to use to ensure they are adequate for its intended phannaceutical usage. For example: your finn manufactured Gabapentin 100 mg/mL Suspension Stock Solution Lot 656519 that may be used in the production of patient-specific drugs. This stock solution can be stored for up to Kb) (4 ) per the compounding record. The compounding record for Gabapentin 100 mg/mL Suspension Stock Solution Lot 6S6519, used in the production of patient dosage Lot 657408, does not describe the container and closure system in sufficient detail. The record states only "Bottle with Insert and Dosing Syringe." without specifying the material or type of container. This level of detail is inadequate to ensure that the selected container and closure system is appropriate for long-term storage of up to [{b)(4) and does not provide sufficient assu

Observation 2 — EM!'I.O~SI S IGNATIJftf DATelMUED SEE REVERSE Lillian S Wu, Investigator 7/17/2026

EM!'I.O~SI S IGNATIJftf DATelMUED SEE REVERSE Lillian S Wu, Investigator 7/17/2026 ,_..,OFTHISPAGE Youkeun Kim, Investigator X ==-~..,,~~ ... FORM .-UA q.J (119/0I) PA.E.V(QUS EIXTION OBSOI..IITE INSPECTIONAL OBSERVATIONS PAGE I of5 PAOES -- 1 of 6 -- DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT ADORESS ANO f'NONE K- wul:(S)OF INSP.,,_,KlH 222 l 5 26th Ave SE Suite 210 7/6/2026-7/17/2026* Bothell, WA 98021 FEINUMBER 3015133983 (425)302-0340 Fax: (425)302-0404 NMIEAADTIIU OF INu,va,u...,_ TO"""'" .....-ur<1 ISSUED Chad R. Tinnes, Pharmacist in Charge and General Manager f[RMNAMt STREET ADORES$ Cascade Specialty Pharmacy, LLC 19062 State Highway 305 NE CITY, STATI! , ZIP CODI!, GOUN'TRY TYP1: ESTAIIUSHMl:NT INSPECTEDn j Poulsbo, WA 98370-7336 . •• .,~, _ _ 1 rn,alJ.l't.,.of No ... -s~·,Q,..pl1-lj PrJ.~ c,h p - U7}i f 74-i,~ • Batch production and control records do not include complete infonnation relating to the production and control of each batch. Specifically, A. Amoxicillin/Clavulanate Pot 250 mg/mL Suspension Lot 657973 (RX# F wxc1) Your finn's compounding record does not specify the method to be used for crushing or dissolving tablets during pr

Observation 3 — Written procedures are not established for the cleaning and maintenance of equipment,

Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. Specifically, EMPU>YEE(S ) SIGMT\JRE CV.ll:i lSSU'Sl) SEE REVERSE Lillian s Wu, Investigator 7/17/2026 OF THIS PAGE Youkeun Kim, Investigator X PAGE 2 ofS PAGES FOR.'11 YD.\ 4113 (09~ PIUVIDIJS ED!TIO~ 06SDl.£TI! INSPECTIONAL OBSERVATIONS -- 2 of 6 -- DEPARTMENT OF HEAL TR AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISUICT AOORESS ANO PHO Nl: N!JM61,R DA1c10>JOI' 1N SPew110N 22215 26 th Ave SE Su it e 210 7/6 / 2026 -7 /17 / 2026 * Bothel l , WA 98021 FSN\JMBER 3015133983 (425) 302-0340 Fax: (425) 302-0404 NAME ANOTITU OF INDI\IIDU M. TO WHOM REPORT ISSUED Chad R. Tinnes, Pharmacis t in Charge and Gene r al Manager ftRMNAME Cascade Specialty Pharmacy, LLC 19062 State Hi ghway 305 NE ;:·:;::o~~;u:3 7 0- 7336 ~EST~ENT t:ioc!1tce,r J. Non-~~(e PrtA.j f,-cxJ~ S. I.JUI 07(\7 ('1,,0'2.,lt:, . Your finn has not conducted an in-house efficacy study to verify the effectiveness of the deactivating agent used for beta-lactam residue on production equipment from manufacturing and handling beta lactam drug subst

Observation 4 — Testing and release of drug product for distribution do not include appropriate

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to ~e identity and strength of each active ingredient prior to release. Specifically, Your firm perfonns routine potency testing only on in-process materials for Levothyrox.ine Sodium and Liothyronine Sodium. Your firm does not perform routine finished product testing on manufactured drug products. For example: A. Trilostane Capsule 58 mg Lot 660349 (RX# iCb> <5>. <bl (7)(CJ Your firm did not perform identity or strength testing on this finished drug product prior to release. Conformance to the labeled potency of 58 mg was not analytically verified; release was based solely on theoretical potency calculated from the quantities of components used during production. B. Gabapentin 100 mg/mL Suspension Lot 657408 (RX# f H5J. <bJ(7)(CJ Your finn did not perfonn identity or strength testing on this finished drug product prior to release. Conformance to the labeled concentration of 100 mg/mL was not analytically verified; release was EMPl.0-.a!(S I SIGHAT\JRE DATliilSSUED SEE REVERSE Lillian s Wu, Investigator 7/17/2026 OF THIS PAGE Youkeun Ki rn, I nves t i

Observation 5 — . Specific identification tests are not conducted on components that have been accepted

. Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis. Specifically, Your firm accepts the material based on the supplier's certificate of analysis in lieu of testing each components received. However, your firm does not perform identity tests each component received to ensure that the component received has purported identity. The following components based solely on the supplier's COA without performing any identity testing: A. Trilostane powder Lot[(b) (4) , which was used to compound Trilostane Capsule 58 mg lot 660349, was accepted without any identity testing. Only the CoA of supplier was used for release for usage. B. Methimazole powder lot l(b) (4) , which was used to compound Methimazole Stock solution lOmg/rnL lot 647915, was accepted without any identity testing. Only the CoA of supplier was used for release for usage. C. Itraconzole powder lot [(b) _(4) , which was used to compound Itrazonzole 25mg/mL Suspension lot 652087, was accepted without any identity testing. Only the CoA of supplier was used for release for usage. In addition, your firm has not demonstrated the reliability of your suppl

Observation 6 — There is no written testing program designed to assess the stability characteristics of

There is no written testing program designed to assess the stability characteristics of drug products. Specifically, Your firm does not have written stability testing program to determine the beyond use date for each drug r product. Your firm assigns beyond use date based on the [ b) (4) , which is based on either stability testing performed by other entity for in-process stock, or based on the dosage form and the storage condition. *DATES OF INSPECTION 7/06/2026(Mon), 7/07/2026(Tue), 7/08/2026(Wed), 7/09/2026(Thu), 7/10/2026(Fri), 7/13/2026(Mon), 7/14/2026(fue), 7/15/2026(Wed), 7/16/2026(Thu), 7/17/2026(Fri) ,_..... SEE REVERSE OF THIS PAGE l!MJ'LO'rE.e(S)SIGNA~ Lillian S Wu, Investigator Youkeun Kim, Investigator "- · MTEIS.SU&O 7/17/2026 X PAGE SofHAOES fOII.M FDI\ oC3J (117JV8) ~VIOUS wmo~ OllliOUml INSPECTION AL OBSERVATIONS -- 5 of 6 -- The observations of objectionable conditions and practices listed on the front of this fonn are reported: 1. Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or 2. To assist firms inspected in complying with the Acts and regulations enforced by the . Food and Drug Administration. Section 704(b) of the Federal Food, Drug,

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.

Cascade Specialty Pharmacy LLC’s FDA history

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

Frequently asked questions

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 Cascade Specialty Pharmacy LLC had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for Cascade Specialty Pharmacy LLC so far. Argus ingests new FDA records daily.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3015133983.
Is a Form 483 the same as a Warning Letter?: No. A Form 483 lists an FDA investigator’s observations at the close of an inspection; it is not a final agency determination. FDA may or may not follow up with a Warning Letter depending on the firm’s response and the severity of the findings.

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

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Full FDA history for Cascade Specialty Pharmacy 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). July 17, 2026 FDA Form 483 for Cascade Specialty Pharmacy LLC — 6 Citations. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/483/cascade-specialty-pharmacy-3015133983-2026-07-17

MLA

"July 17, 2026 FDA Form 483 for Cascade Specialty Pharmacy LLC — 6 Citations." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/483/cascade-specialty-pharmacy-3015133983-2026-07-17.

Chicago

Argus HQ Research. "July 17, 2026 FDA Form 483 for Cascade Specialty Pharmacy LLC — 6 Citations." Digital Empire Holdings LLC. Accessed August 1, 2026. https://argushq.ai/483/cascade-specialty-pharmacy-3015133983-2026-07-17.

BibTeX

@misc{argushq_argushq_ai_483_cascade_specialty_pharmacy_3015133983_2026_07_17_2026,
  title = {July 17, 2026 FDA Form 483 for Cascade Specialty Pharmacy LLC — 6 Citations},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/483/cascade-specialty-pharmacy-3015133983-2026-07-17},
  note = {Accessed: August 1, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗