Has Carolina Infusion had other FDA inspection citations?

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

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

FEI / inspection ID: 3015826782.

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.

FDA Form 483 — Carolina Infusion (January 24, 2025)

Here's the summary: FDA inspected Carolina Infusion in South Carolina and issued a Form 483 listing 4 inspectional observations following an inspection that concluded 2025-01-24. FDA records classify Carolina Infusion 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.

Key facts

Firm	Carolina Infusion
FEI / inspection ID	3015826782
Inspection end date	January 24, 2025
Citation count	4

Citations explained

Observation 1 — Materials were exposed to lower than ISO 5 quality air

Materials were exposed to lower than ISO 5 quality air. Specifically, A. The [( l:5) (.2J ) Iswabs u sed to collect samples of comp ounded diug products intended for sterility testing were obser ved to have been open ed and pl aced in the ISO 7 area. For example: • On 1/15/2025, during the compounding of TRI-MIX 30/2/40 Injecta ble, Lot# 0 11 52025 @0 BUD 2/10/2025, it was observed that the operator filter ed a di·o p of the so lution intended to be sterile onto a swab that had been open ed and exposed to the ISO 7 hallway while being caITi ed to the ISO 5 Biological Safety Cabinet (BSC), Equipment ID 49302 located in Compounding R oom :!tiff•> • On 1/15/2025, during the compounding of TEST CYP/DHEA (S ESAME) 200 mg/2.5 mg/ml, Injectable Lot# 0 11 52025 @:J BUD 2/14/2025, it was observ ed that the operator opened a new b ag of swabs to.

Observation 2 — Inadequate routine environmental monitoring in the ISO 5 area

Inadequate routine environmental monitoring in the ISO 5 area. Specifically, Environmental monitoring (EM) of the ISO 5 LAFH and BSC is inadequate. Air sampling for environmental monitoring in each ISO 7 compounding room is conducted[(6) (4) Iby a third-paiiy company; however, active air monitoring and the use of settle plates have never been conducted in these ISO 5 areas. There ai·e 4 (b) (4 )ISO 5 LAFHs in Compounding Room :ttin•·and r(bH f ISO 5 BSCs in Compoundm . g Room!1>1(4)

Observation 3 — Failure to conduct m edia fills that closely simulate aseptic production operations

Failure to conduct m edia fills that closely simulate aseptic production operations un de r the worst-case, most-challeng ing, and stressful conditions. Specifically, EMPLOYEE(S) SI GNATURE DATE ISSUED SEE REVERSE Taichun Qin, I nves t iga t or 1 /24/2025 OF THIS PAGE T.....,or, S By: 2001321646 X ..,.. = r. OHA-202S F ORM FDA ~83 (09/ 08) PAGE2 of5 PAGES PREVIOUS EDmON OBSOLEJE INS PEC TIONAL OB SERVATIONS

Observation 4 — Lack of dis infection of supplies at each transition from areas of

Lack of dis infection of supplies at each transition from areas of lower quality a ir to areas of higher quality air. Specifically, A. The operator did not thoroughly disinfect supplies, such as needle packages, with[(6) (4) Ibefore introducing them into the ISO 5 LAFH from the ISO 7 are a. On 1/14/2025 and 1/15/2025, during the compounding of S e1morelin Acetate Injection, 1 mg/ml, Lot# 01142025 @rj, BUD 2/28/2025 and TEST CYP/DHEA (SESAME) 200 mg/2.5 m g/ml, Injectable Lot# 011 52025 @0 BUD 2/14/2025, the operator sprayed multiple needle packages while holding them together in her hands with b) (4) I, leaving the contact s urfaces between the needles insufficiently dis infected. B. The paper-like b ag containin&.( 6) (4) cotton swabs, used to sample sterile products for microbiology testing, was not disinfected prior to being introduced into the ISO 5 LAFH or BSC given I EMPLOYEE(S) SI GNATURE DATE ISSUED SEE REVERSE Taichun Qin, I nves t iga.

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.

Carolina Infusion’s FDA history

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

Frequently asked questions

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

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

Free weekly briefing tracks every FDA inspection outcome.

Full FDA history for Carolina Infusion

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 (2025). FDA Form 483 — Carolina Infusion (January 24, 2025) — 4 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-carolina-infusion-2025-01-24-3015826782

MLA

"FDA Form 483 — Carolina Infusion (January 24, 2025) — 4 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-carolina-infusion-2025-01-24-3015826782.

Chicago

Argus HQ Research. "FDA Form 483 — Carolina Infusion (January 24, 2025) — 4 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-carolina-infusion-2025-01-24-3015826782.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_carolina_infusion_2025_01_24_3015826782_2025,
  title = {FDA Form 483 — Carolina Infusion (January 24, 2025) — 4 Citations},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-carolina-infusion-2025-01-24-3015826782},
  note = {Accessed: July 15, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗