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 Fresenius Kabi Compounding 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 Form 483 — Fresenius Kabi Compounding LLC (November 5, 2025)

Here's the summary: FDA inspected Fresenius Kabi Compounding LLC in Massachusetts and issued a Form 483 listing 6 inspectional observations following an inspection that concluded 2025-11-05. FDA records classify Fresenius Kabi Compounding 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.

Key facts

Firm	Fresenius Kabi Compounding LLC
FEI / inspection ID	3013438665
Inspection end date	November 5, 2025
Citation count	6

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 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 i ts componen ts to meet any of its specifications whether or not the batch has been akeady distribute d. Specifically, yo ur fnm detected defects in E,<4 infusion and~ )l Y inj ection po1ts on some of the IV bag container closures of yo ur compounded sten le dmg productt [CSP's). Defects include the po1t not being properly fused to the IV bag and may lead to leaking, po1t fa lling o ff the IV bag with minimal manipulation, or other conta iner closure integrity issues. These defects affect units in multiple lots of multiple products, fo r example: 1 6 4 - - Vancomycin HCl 1. 25 grams added to 250 mL 0.9% Sodium Chloride Injection USP IV Bag, Preservative Free, Lot C274-000048802, MFG 10/6/2025, EXP 4/4/2026 Phenylephrine HCl 20 mg added to 250 mL (80 mcg/mL) 0.9% Sodium.

Observation 2 — Procedures designed to prevent microbiological contamination of mug products pmpo1ting to be

Procedures designed to prevent microbiological contamination of mug products pmpo1ting to be sterile are not established, written and followed. Specifica lly, a. Multiple examples were observed in which procedures regarding operator conduct were not established or followed: 1. During van co mycin reconstitution operations on 10/ 17/25, multiple instances were observed in which operator movements inside ISQlin' (6) (~] laminar fl ow hoods obstructed first-pass air to uncapped vials of [(6) -( 4) I vancomycin. For example, during vial reconstitution for production of Van co mycin HCl 1.75g Bag lot C274- 000048979 in Laminar Flow Hood 11 • , we observed an operator 's aims pass between first-pass air and pre- and post-dilution vials. This occmTed while the operator was obtaining undiluted vials fr om the rack, returning reconstituted vials to the rack, and AMENDMENT 1 EMPLOYE E($) SIGNATURE DATE lSSUEO SEE REVERSE Jona tha n G Matrisciano, I nves ti ga t o r 11 /6/2025 OF THIS PAGE.

Observation 3 — The responsibilities and procedures app li cable to the quality control unit

The responsibilities and procedures app li cable to the quality control unit are not fully fo ll owed. Speci fi ca lly, your fnm has been using mug products known to be defective (defective ports on [( 6) {4 IV bags) fo r compounding since 10/2024. Among the 11 • batches of CSP's made at least in part from the initia lly identifi ed defective IV bag lot (l ot 23SU10008) ,r batches were fully distributed to customers. While DEV-2024-1626 states that this defect is highly detectable during visual inspection, your fnm opened Issue-2024-0039 on 7/26/2024 for operators fa iling visual inspection requa li fication fo r IV bags. l SOP FSSBOS -SOP-0018 " Visual inspection _of Compounded Sterile Products" indicates that the allowable defect liinit fo r critical po1t defects i fl %, yet your fnm released lots with po1t defects above "' %, such as van co mycin HCl 1 gram added to 250 mL 0.9% Sodium Chloride.

Observation 4 — Your examination and testing of samples did not assure that the drng

Your examination and testing of samples did not assure that the drng product and in-process material con fo1med to specifi cations. Speci fi ca lly, on 10/ 10/20 25 , your fnm's visual inspection hoods including EOOl 13 .00 in Room f(.J we re observed to conta in dust-like pa1ticles on the 4 (b) ( visual inspection backgrounds. Your fnm also lacks a written procedure fo r cleaning of [(6) (~) sur aces in the visual inspection hoods including backgroun ds. On 10/16/2025, during visual inspection of lot C274-000048970 of oxytocin D USP units added to 500 mL 0.9% Sodium Chloride Injection, USP IV Bag, we observed dust-like pa1ticles on the {t> {4 backgroun ds in the visual inspection hoods that the inspectors were using.

Observation 5 — Aseptic processing areas are de fi cient regarding the system fo r

Aseptic processing areas are de fi cient regarding the system fo r monitoring environmental conditions. Speci fi ca lly, active viable air sampling was not per fo1med at a time representative of production operation s. The fnm perfo 1ms active viable air sampling a ft er operators folly conclude a stage of diug production, i.e., reconstitution, pooling, or filling, in accor dance with the fnm's environmental monitoring procedures. Additionally, settling plates in the 1sd'1 ., hoods are not always placed in a location representative of production activities, as observed on 10/17/ 25 during vial reconstitution fo r Vancomycin HCl 1.75g Ba~lot C274-000048979 in H oo d □ and pooling of Oxytocin 1 (4 Uni ts Bag lot C274-000048976 in Hood ], as we ll as on 10/10/25 during filling of Lidocaine 2% 5mL Syringe lot C274-000048894 in Hood i<

Observation 6 — Aseptic processing areas are de fi cient regarding the system fo r

Aseptic processing areas are de fi cient regarding the system fo r cleaning and disinfecting the room and equipment to produce aseptic conditions. AMENDMEN T 1 EMPLOYE E($) SIGNATURE DATE lSSUEO SEE REVERSE Jon atha n G Matri sc ia no , I n ve s tigat o r 11 /6/202 5 OF THIS PAGE Lo ri M Newma n , I n ve s tigat o r """' ' Zh"1!1 Da n ie l L Zhen g, I n ve s tigat o r a-,L ~ <: 11-06--202S X •a,:1

Fresenius Kabi Compounding LLC’s FDA history

Argus HQ has recorded 1 total FDA action tied to Fresenius Kabi Compounding 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 Fresenius Kabi Compounding 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.

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Full FDA history for Fresenius Kabi Compounding 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 Form 483 — Fresenius Kabi Compounding LLC (November 5, 2025) — 6 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-fresenius-kabi-compounding-llc-2025-11-05-3013438665

MLA

"FDA Form 483 — Fresenius Kabi Compounding LLC (November 5, 2025) — 6 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-fresenius-kabi-compounding-llc-2025-11-05-3013438665.

Chicago

Argus HQ Research. "FDA Form 483 — Fresenius Kabi Compounding LLC (November 5, 2025) — 6 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-fresenius-kabi-compounding-llc-2025-11-05-3013438665.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_fresenius_kabi_compounding_llc_2025_11_05_3013438665_2025,
  title = {FDA Form 483 — Fresenius Kabi Compounding LLC (November 5, 2025) — 6 Citations},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-fresenius-kabi-compounding-llc-2025-11-05-3013438665},
  note = {Accessed: July 15, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗