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.

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 CD Pharmacy LLC dba Red Rock Pharmacy 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.

CD Pharmacy LLC dba Red Rock Pharmacy — FDA Form 483 Inspection, July 31, 2026 (7 Citations)

Key facts

Firm	CD Pharmacy LLC dba Red Rock Pharmacy
FEI / inspection ID	3032406608
Inspection end date	July 31, 2026
Citation count	7

Key takeaway: FDA inspected CD Pharmacy LLC dba Red Rock Pharmacy in Utah and issued a Form 483 listing 7 inspectional observations following an inspection that concluded 2026-07-31. FDA records classify CD Pharmacy LLC dba Red Rock Pharmacy as a producer of sterile and 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.

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 — Your furn released drug product in which the strength differs from, or its purity or

Your furn released drug product in which the strength differs from, or its purity or quality falls below, that which it pmports or is represented to possess. Specifically, a technician identified a suspected glass particle in one vial during visual inspection ofLiraglutide Injection, 6 mg/mL, lot 042026CH01. BUD 07/19/26. The OOS investigation authorized a technician to recover.Kb ) ('4 ) and then fill the solution as Liraglutide Injection. 6 mo/ mL, lot 051426CR26, BUD 08/12/26. There is inadequate stability data to support the approximately 90-day BUD assigned to the(D) (4)[ 1ot that was originally fonnulated and( b) (4) on 04/20/26. The new BUD is 24 days beyond the original 90-dfi BUD for the solutr.011. T ere was no confinnation of the particle identity or its source. Your finn dispensed, (1>)14} tmits from the ~(l5) 4) lot. Exan1ples include Rx 6 t •H i7ti)(7Xj delivered 07/ 15/26; RxfH 6 ).(b)(7)(CI , delivered 07/10/26; Rxrn6>~ 17x0 1, delivered 07/08 26; and Rx 6 fH i(bJ (7)(9. delivered 06 0372026.

Observation 2 — Fai hu·e to conduct media fills that closely simulate aseptic production operations tmder

Fai hu·e to conduct media fills that closely simulate aseptic production operations tmder the worst-case, most-challenging, and stressfol conditions. Specifically, media filJ.£rocedures and executed records do not reflect the various production activities I watched. Your fu-111 ctm·ently aseptically fills about( b) (4) vials per day, and filled aboud b) (4) lots of sterile injectable dmgs in the previous two years. A.Media fills do not simulate the most challenging production conditions. I watched" b) <4 l technicians simultaneously fill. stopper, and cap vials from two lots inside the same ISO 5 hood dmiug filling of multiple lots from Semaglutide Injection, 2.5 mg/mL stock solution lots 072126CRS1, 072126CRS2, and 072226CH-S25-01; and Tirzepatide-Metl1ylcobalamin Injection, 17 mg- l00mcg/mL stock solution lots 072126CR-TM17- 01 and 072726CH-TM17-01. Teclmicians fill, stopper. and cap vials independently dm111g me.dia fill. B.Technicians used dehydratedl(E_[l4) I modified ,~it½_[(6 ) ( 4) I during the most recent media fills for'C6J<•! technicians in July 2026. The manufacturer's infonnation indicates this 4 (b) < > is intended for the selective enrichn1ent of enterohemoll'hagic E

Observation 3 — Smoke studies were inadequately perfom1ed under dynamic conditions. Specifically, A. One

Smoke studies were inadequately perfom1ed under dynamic conditions. Specifically, A. One technician, one syringe, and one vial present in the ISO 5 hoods dming the smoke studies conducted in January 2026 was not representative of routine production. Items I observed u1 the hood dming filling of multiple lots from Semaglutide Injection, 2.5 mg/mL stock soluti on lots 072126CRS1 , 072126CRS2, and 072226CH-S25-01 ; and Tu·zepatide:Methylcobalamu1 Injection, 17 mg-1 OOmcg/mL stock solution lots 072126CR-TM17-01 and 072726CH-TM17-01 mclude: 4 '{b) ( 1 technicians. one repeater pump, ( b) (4 tb11lll bags and tubmg ~J hangmg from the IV bar, one tray of glass vials, one bag of stoppers, one bag or caps, multiple forceps, a sleeve ot[(l:5) (4 plates, and other items. B. Operations within tneISO 3 hood and ISO 7 buffer room were not representative of routine production conditions. One technician sunulated ptmcniring a vial septmn while one person held the handheld smoke generator dming the smoke study. Conditions I observed that were not evaluated durmg the smoke study mclude l 6l (lll technicians filling. stoppe1ing, and capping vials suuultaneously in the same ISO 5 hood. C. Insufficient

Observation 4 — Materials were exposed to lower than ISO 5 quality au·. Specifically, I observed several

Materials were exposed to lower than ISO 5 quality au·. Specifically, I observed several sterile items exposed u1 the ISO 7 buffer room dming filling of multiple lots from Semaglutide Injection, 2 .5 mg/mL stock solution lots 072126CRS1, 072126CRS2. ai1d 072226CH-S25-0 1; atid Tu·zepatide-Methylcobalamu1 Injection, 17 mg l00mc2/ mL stock solution lots 072126CR-TM17- 01 and 072726CH-TM17-01. A:· Technicians remove sterile wipes from the package atid place them on t op of the package on a table m the ISO 7 Hood Room (buffer room). I saw wipes remau1 exposed to the envu·onment for more than one hom· ai1d observed multiple bags of caps placed directly on top of the wipes. Technicians sprayed sterile~ 6 J(4 )l on these wipes atid used them to disu1fect surfaces inside the ISO 5 hoods. B. fFor~eps pm-d1ased sterile were stored exposed u1 the ISO 7 buffer room for an mdefinite amount of time, sanitized with~bJ f4 j 1 J j, and then used to put stoppers u1to filled vials of s emaglutide mjection. C. [ 1:5) J4) I trays used as a du·ect contact surface for vials and stoppers mside the ISO 5 hood are sterilized iii-house atid then remain exposed u1 the ISO 7 buffer room for an nnspecified aino

Observation 7 — Personnel were observed touching equipment or other surfaces located outside of the ISO S

Personnel were observed touching equipment or other surfaces located outside of the ISO S area with gloved hands and then proceeding with aseptic processing without changing or sruutizing gloves. Specifically, a technician repeatedly placed their gloved hand on the edge of the work sm-face in the ISO 5 hood for up to two nunutes at a tin1e during filling of Semaglutide Injection, 2.5 mg/mL. lot 072726KH-S25- 0l. A~roximately half or more of the gloved hand was outside of the ISO S hood and then reentered without sanitizing with sterilei{b) (4 l OB SE RVATION 8 Inadequate post-use filter-integrity testing on filters used to sterilize drug products. Specifically, the~4) __J digital pressure gauge, S/N1 ~(61 • (4) J attached to theKP)_JiC__J tester has been in-use about three years but has not been calibrated to confinn the accuracy o readmgs fo r tlus critical test. Personnel re-cord pressure readings from this gauge durind D) H ) I tests for all sterile drug lots. Examples of drug lots produced a11d dispensed after[(D) (4) I testing witli this gauge include: • Semaglutide Injection. 2.5 mg/mL. lot 061526CH06 • Semaglutide-Glycine Injection, 5 mg-2mg/mL, lot 060826CH02 • Tirzepatide-

Observation 9 — Personnel inadequately sanitized gloves to prevent contanunation. Specifically,

Personnel inadequately sanitized gloves to prevent contanunation. Specifically, tedmicians repeatedly failed to thoroughly sanitize gloved hands during filling of multiple lots from Semaglutide Injection, AMENDMENT 1 EMPI.OYEE(S) SIGNATURE DATE ISSUED SEE REVERSE Nicholas L Hunt, Senior cso 07/31/2026 _,_ OF THIS PAGE ...... coo 81gneG8')':Htchohl$Ll-b'll4 ~llt' 81gne«07·l1-2026 X 13:1':56 PAGE4of5PAGES FORM FDA 483 (09/08) PREVIOUS BDmON OBSOLETE INSPECTIONAL OB SERVATIONS -- 4 of 6 -- _,_ ...... coo 81gneG8')':Htchohl$Ll-b'll4 ~llt' 81gne«07·l1-2026 1l:1':S6 X FORM FDA 483 (09/08) PAGE 5of5 PAGES PREVIOUS BDmON OBSOLETE INSPECTIONAL OBSERVATIONS DEPARTMENT OF HEALTH AND HUMA1"1 SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION 6th & Kipling St . (P.O . Box 25087) 07/21/2026 - 07/31/2026* Denver, co 80225 - 0087 F EI NUMBER 3032406608 (303)236-3000 Fax: (303)236-3100 NAME AND TITLE OF INOIVJOUAL TO WHOM REPORT ISSUED Shixian Wang, Director of Operations F IRM NAME STREET ADDRESS CD Pharmacy, LLC dba Red Rock Pharmacy 863 w 450 s Ste 101 CITY, STATE, ZIP CODE, COUITTRY TYPE ESTABUSI-MENT INSPECTED Springville, UT 84663 - 2299 producer of

Observation 10 — Hazardous chugs were produced without providing adequate containment. segregation, and/or

Hazardous chugs were produced without providing adequate containment. segregation, and/or cleaning of work swfaces, utensils, and/or personnel to prevent cross-contamination. Specifically, A. The technician did not change wipes with sufficient frequency during the deactivation and decontamination process of capsule equipment, utensils and the BSC after producing Clom.iphene Capsule s, lot 07282026RW01. The technician used one approxiniately'(b) (41 inch wipe to decontaminate the entire interior of the BSC and used one wipe to decontaminate all the parts of tl1e capsule eqwpment. B. The technician did not deactivate and dec-ontaminate the pen used to record capsule weights in the batch record dw-ing production of Clomiphene Capsules, lot 07282026RW0 1. *DATES OF INSPECTION 7/2li2026(Tue). 7/22/2026(Wed), 7/ 23 /2026(11m). 7/24/2026(Fri), 7/ 27/2026(Mon), 7/28 /2026(Tue), 7/ 29/2026(Wed), 7/30/2026(11m). 7/31/2026(Fri) AMENDMENT 1 SEE REVERSE OF THIS PAGE EMPI.OYEE(S) SIGNATURE Nicholas L Hunt, Senior cso DATE ISSUED 07/3 1 /2026 -- 5 of 6 -- The observations of objectionable conditions and practices listed on the front of this form are reported: 1. Pursuant to Section 704(b) of the

CD Pharmacy LLC dba Red Rock Pharmacy’s FDA history

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

Frequently asked questions

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.
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 CD Pharmacy LLC dba Red Rock Pharmacy 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.

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

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Full FDA history for CD Pharmacy LLC dba Red Rock Pharmacy

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

Cite this record

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APA

Argus HQ Research (2026). CD Pharmacy LLC dba Red Rock Pharmacy — FDA Form 483 Inspection, July 31, 2026 (7 Citations). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/483/cd-pharmacy-dba-red-rock-pharmacy-3032406608-2026-07-31

MLA

"CD Pharmacy LLC dba Red Rock Pharmacy — FDA Form 483 Inspection, July 31, 2026 (7 Citations)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/483/cd-pharmacy-dba-red-rock-pharmacy-3032406608-2026-07-31.

Chicago

Argus HQ Research. "CD Pharmacy LLC dba Red Rock Pharmacy — FDA Form 483 Inspection, July 31, 2026 (7 Citations)." Digital Empire Holdings LLC. Accessed September 11, 2026. https://argushq.ai/483/cd-pharmacy-dba-red-rock-pharmacy-3032406608-2026-07-31.

BibTeX

@misc{argushq_argushq_ai_483_cd_pharmacy_dba_red_rock_pharmacy_3032406608_2026_07_31_2026,
  title = {CD Pharmacy LLC dba Red Rock Pharmacy — FDA Form 483 Inspection, July 31, 2026 (7 Citations)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/483/cd-pharmacy-dba-red-rock-pharmacy-3032406608-2026-07-31},
  note = {Accessed: September 11, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗