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 Apollo Care 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.

FDA Inspects Apollo Care LLC: Form 483 with 5 Citations (March 27, 2025)

Key facts

Firm	Apollo Care LLC
FEI / inspection ID	3013927023
Inspection end date	March 27, 2025
Citation count	5

In short: FDA inspected Apollo Care LLC in Missouri and issued a Form 483 listing 5 inspectional observations following an inspection that concluded 2025-03-27. FDA records classify Apollo Care 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 — The responsibilities and procedures applicable to the quality control unit are not

The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. Sp ecifically, A) Your quality unit failed to evaluate and approve removal a.ad reloeatiofl of the handwashing sink from the ISO 8 Hallway/ Anteroom. Facility construction within your ISO classified cleanroom was not conducted per SOP CQI002 Management of Change Authorization (MOCA). B) Your written procedure, PRC002 Facility Cleaning Procedure, Rev 15, Effective Date 0 3/01/2025, instructs documentati on ofllifRJ J cycles in Logbook (bH• This record of decontamination/cleaning is deficient, such that it does not capture details to demonstrate the specifications of each cycle meet those established during performance qualification/ validation. Details of ea ch cycle are instead captured in vendor supplied application software accessed through a mobile device. You lack documented validation showing that the application software t hat generates and stores details or~ cleaning/decontamination meet Part 11 requirements for electronic records.

Observation 2 — AMENDMENT 1 EMPLOY EE(S) SlGNATURE DATE ISSUEO SE E REVERS E J

AMENDMENT 1 EMPLOY EE(S) SlGNATURE DATE ISSUEO SE E REVERS E J o lanna A No r t o n , Inves ti ga t o r 3/ 27 /20 25 OF THI S PAG E JollnteANorton St,rd~Jol_...A.No:ir1oll ~ 0.~ 0 3-2N02S X - 18: S8:S1 PAGE 1 of8 PAGES

Observation 3 — Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals

Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. AMENDMENT 1 EMPLOY EE(S) SlGNATURE DATE ISSUEO SEE REVERSE J ol anna A Nor t on , Investigat o r 3/27/2025 OF THIS PAGE JollnteANorton St,rd~Jol_...A.N - o:ir1oll ~ X 0.~03-2N02S 18:S8:S1 PAGE3of8PAGES

Observation 4 — There is a failure to thoroughly review any unexplained discrepancy and the

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. Specifically, A) Your environmental monitoring recovered mold in ISO classified areas after implementing your firm 's Mold Risk Mitigation strategies. Your mitigation strategies include a;;;,L.11,,;;a_ ____-...1 of unclassified product storage areas. You have not investigated to determine a root cause for mold found in your ISO classified clean room suite and therefore lack assurance that your mold risk mitigation strategies are effective to ensure that your injection, infusion, and epidural sterile compounded drug products are produced in aseptic conditions. For example, • On 08 /30/2024 environmental monitoring surface sampling found fungi in your unclassified product storage areas, including Alternaria alternata, Acremonium variecolor, Cladosporium cladosporoides, and Fusarium solari. • On 9/18/2024 environmental monitoring surface sampling of the TSO 8 Anteroom recovered 1 cfu fungi (Acremonim.

Observation 5 — Buildings used in the manufacture, processing, packing, or holding of a drug

Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction and location to facilitate cleaning, maintenance, and proper operations. Specifically, Observation of exposed wood and wall insulation in warehouse storage areas where components and materials used in aseptic areas are stored. These surface[s and] materials are likely to generate particles and may harbor microbiological contamination within material storage areas. Examples of stored materials include: IV bags of normal saline and water for injection, packages holding syringe[s], empty IV bags, -,;;;;ouo.,;;&.,1 bulk storage bags. *DATES OF INSPECTION 3/ 10/2025(Mon), 3/1 1/2025(Tue), 3/l 2/2025(Wed), 3/l 3/2025(Thu), 3/ 14/2025(Fri), 3/17/2025(Mon), 3/ 18/2025(Tue), 3/19/2025(Wed), 3/20/2025(Thu), 3/26/2025(Wed), 3/27/2025(Thu) AMENDMENT 1 EMPLOY EE(S) SlGNATURE DATE ISSUEO SEE REVERSE J ol anna A Nor t on , Investigat o r 3/27/2025 OF THIS PAGE JollnteANorton St,rd~Jol_...A.N - o:ir1oll ~ X 0.~03-2N02S 18:S8:S1

Apollo Care LLC’s FDA history

Argus HQ has recorded 1 total FDA action tied to Apollo Care LLC: 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 Apollo Care 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.

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 Apollo Care 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 (2025). FDA Inspects Apollo Care LLC: Form 483 with 5 Citations (March 27, 2025). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-apollo-care-llc-2025-03-27-3013927023

MLA

"FDA Inspects Apollo Care LLC: Form 483 with 5 Citations (March 27, 2025)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-apollo-care-llc-2025-03-27-3013927023.

Chicago

Argus HQ Research. "FDA Inspects Apollo Care LLC: Form 483 with 5 Citations (March 27, 2025)." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-apollo-care-llc-2025-03-27-3013927023.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_apollo_care_llc_2025_03_27_3013927023_2025,
  title = {FDA Inspects Apollo Care LLC: Form 483 with 5 Citations (March 27, 2025)},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-apollo-care-llc-2025-03-27-3013927023},
  note = {Accessed: July 15, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗