Does this Form 483 mean Carolina Infusion 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 Carolina Infusion LLC had other FDA inspection citations?

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

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

FEI / inspection ID: 3015826782.

Form 483 Record: Carolina Infusion LLC, August 18, 2026

Key facts

Firm	Carolina Infusion LLC
FEI / inspection ID	3015826782
Inspection end date	August 18, 2026
Citation count	10

Key takeaway: FDA inspected Carolina Infusion LLC in South Carolina and issued a Form 483 listing 10 inspectional observations following an inspection that concluded 2026-08-18. FDA records classify Carolina Infusion LLC 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 — There is a lack of HEPA-filtered air and an inadequate HEPA filter coverage or airflow

There is a lack of HEPA-filtered air and an inadequate HEPA filter coverage or airflow over the critical area to which sterile drug product is exposed. Specifically, on I (15 ) (4) l, after the manufacture of tirzepatide for injection 26mg/ml lot 0805202~<bH4 J} and tirzepatide/cyanocobalamin for injection 26 mg/2mg per ml lot 0805202 6(b)(4 l, the I (b) (4 ) [(b) (4 )] laminar flow hood (ISO-5) was operating with a pressure gauge reading of zero, indicating a failure to maintain the positive pressure required to protect the critical aseptic processing area from the influx of lesser quality air. You failed to use an appropriate anti-microbial preservative to prevent microbial proliferation within containers of multi-dose sterile drugs. Specifically, I (b) (4 ) I bulk stock solutions of drug products, such as tirzepatide, are stored in unclassified areas and repeatedly introduced into the ISO-5 environment over a !(15) (4 J, period to draw up patient-speci fi c syringes. This workflow repeatedly exposes the bulk container closure system to unclassified air during storage and introducing contamination risks with each re-entry. You are using I ( 15) (4 ) . This can only inhibit bacter

Observation 2 — The Cleanroom areas contain dust-collecting overhangs without adequate and frequent

The Cleanroom areas contain dust-collecting overhangs without adequate and frequent cleaning. Specifically, on 08/ 05 /2026, visible dust was observed on the inside of the clean room door windowpane adjacent to the I (15) (4) I ISO-5 [(15) (4)1 laminar flow hood in the non-hazardous compounding cleanroom ~! which is used to produce sterile non-hazardous drug products. Throughout the cleanroom suite s, doors and viewing windows feature decorative molding with ridges and ledges. These surfaces are not smooth, or easily cleanable, contributing to particulate accumulation and potential microbial contamination in close proximity to production activities for drug product intended to be sterile. Additionally, wall insulation was exposed and open to the mezzanine and warehouse area. This insulation was on the exterior of the generator room, the exterior of the ante room hallway, and the exterior of the hazardous compounding room Jib)(• The mezzanine and stairs leading to the mezzanine were composed of particle generating wood particle board. In some locations, on the mezzanine, the air ducts were not connected to an exterior venting system.

Observation 3 — InadequateI (6) (4) I on ro) (4) used to sterilize drug products. Specifically, on I (b)

InadequateI (6) (4) I on ro) (4) used to sterilize drug products. Specifically, on I (b) (4) I after the manufacture of tirzepatide for injection 26 mg/ml lot 080520261 4 b >< I EIM'L OYEE(S) SI GNATURE DATE I SSUED SEE REVERSE Joanne E Ki ng, Invest i gato r 8/ 1 8/2026 OF THIS PAGE Rog er F Zab in s ki , Na t i ona l Ex p er t t JoaMO :T~ EKing 1 X 13001 '14867 ~::ts~"od: oa.,a.2026 FORM FDA 483 (0M)8) PAGES PREVIOUSEOffiO OBSOLE'TE INSPECTIONAL OBS ERVATIONS PAGE 2 of7 N -- 2 of 8 -- DEPARTMENT OF HEALTH AND HUMAN SERVICES F OOD AND DRUG ADMINISIRATION lllSTRICT ADDRESS AND PHONE NUMBER DATE( S) OF INSPECTION 1777 Ha r d ee Ave SW 8/5/ 202 6- 8/ 1 8/ 202 6* At l anta , GA 303 10 FEI NUMBER 301 5826782 ( 404)253 - 1284 Fax : ( 404)669 - 4443 NAt.E A NO , 11 ~ OF ....,. v,OUAL TO \MtOM REPORT ISSUED Cour tney M. Nix , Pha r maci st In Cha r ge FflM NAME STREET ADDRESS Ca r o lin a I nfu s i on , LL C 95 Bee s Cree k Rd CITY, STATE, ZI P CODE, COUNTRY TYPE ESTABLISHM ENT IN SPECTED Ridgela nd , SC 29936 - 7540 St e r i le a nd Non- St e r i le Dr ug Ma nu f act u r e r and bulk tirzepatide/cyanocobalamin for injection 26 mg/ 2mg per ml lot 08052026(b) <4) we observed 1111 that the

Observation 4 — Your firm released drug product in which the strength differs from, or its purity or

Your firm released drug product in which the strength differs from, or its purity or quality falls below, that which it purports or is represented to possess. Specifically, the bulk tirzepatide/cyanocobalamin fo r injection 26 mg/2 mg per ml lot 0805202 6{b)(<fl was reprocessed when the I (l:)f(4) l was not performed due to a pressure gauge malfunction. This reprocessing combined the contents of (I>) (41 approximately p:5 f{4j bulk drug vials which were then [ (15) (4) ] and tested for endotoxin and sterility. This reprocessing was performed on I (b) (4) I and the beyond use date assigned was 9/19/2026.

Observation 5 — Smoke studies were inadequately performed under dynamic conditions. Specifically, the

Smoke studies were inadequately performed under dynamic conditions. Specifically, the smoke studies taken on 1/27/2025 in your ISO-5 l(b) (4)] laminar flow hoods and bio safety cabinets did not fully demonstrate laminar flow. These smoke study videos were 4 to 18 seconds long and recorded by I -(6) (4) 1. The video does not show the air flow over the critical sterile drug product preparation areas and the air flow patterns for hoods that are located across from each other. Compounding room lbH4 l contains :!l>l (<il ISO 5 biosafety cabinets positioned facing each other, approximately 2-3 feet apart. One hood is designated for nuclear blood tagging, and the other is used for the production of testosterone cypionate injectable product intended to be sterile. No smoke study has EIM'LOYEE(S) SI GNATURE DATE I SSUED SEE REVERSE Joanne E Ki ng, Invest i gato r 8/ 1 8/2026 OF THIS PAGE Rog er F Zab in s ki , Na t i ona l Ex p er t JoaMO EKing t :T~1 X 13001 '14867 ~::ts~"od: o a. ,a.2026 FORM FDA 483 (0M)8) AGES PREVIOUSEOffiON SOLE'TE INSPECTIONAL OBS ERVATIONS PAGE 3 of7 P OB -- 3 of 8 -- DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISIRATION lllSTRICT ADDRESS AND PHONE NU

Observation 6 — The facility is designed and/or operated in a way that permits poor flow of personnel or

The facility is designed and/or operated in a way that permits poor flow of personnel or materials. The warehouse / material receiving and product shipping area was found to have the following deficiencies: • Open insulation and unfinished construction was observed in the warehouse on the wall between the cleanroom and warehouse. • A recycling room at the back of the main warehouse / material receiving and shipping room is used for cleaning and storing the lead containers (pigs) used for shipping the radiopharmaceutical patient doses (syringes). In this recycle room, we observed that the firm is storing lead shipping containers (pigs) and radioactive waste such as Technetium Tc99m, Gallium Ga68 Netspot labeled containers, and Iodine 1-123 capsules. The firm is disassembling I (b) (4) J radioactive generators used for production of Technetium Tc99m. Plastic containers, lead, metal and residue from these items was observed in this recycle room. Dead roach(es), dust and debris was also observed in this recycle room. • The firm lacks controls to prevent cross contamination of lead, lead particles, and other debris from the recycle room through the rest of the facility. • A door connect

Observation 7 — Hazardous drugs and Highly potent drugs were produced without providing adequate

Hazardous drugs and Highly potent drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination. A. Specifically, testosterone compounding (a highly potent hormone), chemotherapy reconstitution (hazardous drugs), and blood radiolabeling (biohazardous material) are all performed within the same cleanroom '!bH4 I using 0 < ><4> hoods in close proximity. There is no physical separation between the biohazardous blood handling area and the areas where non-blood products are handled. Furthermore, a shared supply table was observed containing materials for both testosterone compounding and blood radiolabeling activities, demonstrating inadequate dedication and segregation of equipment based on risk. Each of these high-risk activities requires fundamentally different decontamination approaches blood-borne pathogen decontamination, hazardous drug deactivation, and hormonal drug decontamination, respectively. The firm has not demonstrated through documented procedures or supporting evidence that the shared room, work surfaces, and equipment are adequately cleaned and decontaminated when tra

Observation 8 — Lack of and Inadequate routine environmental monitoring in the ISO 5 area and classified

Lack of and Inadequate routine environmental monitoring in the ISO 5 area and classified areas. Your staff stated they perform I(lj) (4) I surface sampling within the ISO 5 and ISO 7 area after cleaning and disinfection. Sampling after cleaning does not accurately represent your production environment. Additionally, your staff also stated and demonstrated that when [(l5) (4 ~ plates are unavailable, the firm's procedure is to use I (6) (4) , ( I:> ) (:it) on a surface, and then l6TT41that I (6) (4) I onto an t6TT41 plate as EM surface sampling. A l (b) (4) alone will not efficiently lift or release microorganism from a ltiH.Jl surface on to an 4 (bH 1 plate compared to a pre-saturated swab. This method also does not include the use of neutralizing buffer which is necessary to neutralize residual disinfectants. This calls into question the validity of your test results.

Carolina Infusion LLC’s FDA history

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

Frequently asked questions

Does this Form 483 mean Carolina Infusion 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 Carolina Infusion LLC had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for Carolina Infusion LLC so far. Argus ingests new FDA records daily.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3015826782.

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Full FDA history for Carolina Infusion 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). Form 483 Record: Carolina Infusion LLC, August 18, 2026 — 10 Citations. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/483/carolina-infusion-3015826782-2026-08-18

MLA

"Form 483 Record: Carolina Infusion LLC, August 18, 2026 — 10 Citations." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/483/carolina-infusion-3015826782-2026-08-18.

Chicago

Argus HQ Research. "Form 483 Record: Carolina Infusion LLC, August 18, 2026 — 10 Citations." Digital Empire Holdings LLC. Accessed September 23, 2026. https://argushq.ai/483/carolina-infusion-3015826782-2026-08-18.

BibTeX

@misc{argushq_argushq_ai_483_carolina_infusion_3015826782_2026_08_18_2026,
  title = {Form 483 Record: Carolina Infusion LLC, August 18, 2026 — 10 Citations},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/483/carolina-infusion-3015826782-2026-08-18},
  note = {Accessed: September 23, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗