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 Eagle Pharma Outsourcing 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 Eagle Pharma Outsourcing LLC: Form 483 with 5 Citations (February 27, 2025)

Key facts

Firm	Eagle Pharma Outsourcing LLC
FEI / inspection ID	3011688532
Inspection end date	February 27, 2025
Citation count	5

In short: FDA inspected Eagle Pharma Outsourcing LLC in Alabama and issued a Form 483 listing 5 inspectional observations following an inspection that concluded 2025-02-27. FDA records classify Eagle Pharma Outsourcing 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.

Citations explained

Observation 1 — Procedures designed to prevent microbiological contamination of drug products purporting to be

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established. Specifically, A. Your firm management failed to conduct a smoke study for the design of the ISO 5 Filling Cleamoom, which contains an open[(l:>)(4) I flow ISO 5 LAFU and an enclosed ISO 5 Filling System to ensure adequate airflow for the prevention of possible contamination. B. During a review of your firm's vial filling machine (VFM) dynamic smoke study dated [(b)(4) J located within your ISO 5 Filling cleanroom, I observed turbulent eddy currents created while Kl:>}(4) I rubber stoppers into the designated carousel in the presence of non- stoppered vials. During observation of vial filling for the drug product, Triamcinolone Acetonide 50mg/mL, Lot #[(I:>) (4) l, Expiry 2/20/2026, the rubber stopper carousel was refilled in the presence of open vials, which has the potential of becoming contaminated with particulate matter from the sterilized stopper bag. The vial filling machine is not designed.

Observation 2 — Protective apparel is not worn as necessary to protect drug products from

Protective apparel is not worn as necessary to protect drug products from contamination. Specifically, your firm's environmental sampling technician was observed poor sterile re-gowning techniques within your firm's ISO 7 [(15)(~) Jused during aseptic processing by leaning against the wall rendering the gown non-sterile prior to entry into the ISO 5 Filling room for vial filling of the drug product, Triamcinolone Acetonide S0mg/mL, Lot# (t:>) (4) , Expiry 2/20/2026.

Observation 3 — Equipment and utensils are not sanitized at appropriate intervals to prevent contamination

Equipment and utensils are not sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. Specifically, your firm's environmental sampling technician failed to disinfect stainless steel pan containing EM sampling plates and particle counter prior to transfer from the (b)(4) j connecting the ISO 7 Lab Cleanroom and t h.e ISO 5 Filling Cleanroom. This is a repeat observation.

Observation 4 — Equipment used in the manufacture, processing, packing or holding of drug products

Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use. Specifically, during observation of vial filling for the drug product, Triamcinolone Acetonide S0mg/mL, Lot #.( 5) (4) J, Expiry 2/20/2026, I observed an approximate 2-inch diameter hole within the stainless-steel plate used to cover the l(b)(4) Ibeaker containing the bulk drug product creating a potential foreign particulate entry point. The center hole remained uncovered within your firm's ISO 7 Lab Cleanroom, during transfer, and while undergoing vial filling within the ISO 5 Filling Cleanroom. At no time during formulation, bulk drug cleanroom transfer, and filling was the hole covered.

Observation 5 — EMP1-0YEE(S) SIGNATURE DATE I SSUED SEE REVERSE Camerson E Moore, Investigator 2/27/2025

EMP1-0YEE(S) SIGNATURE DATE I SSUED SEE REVERSE Camerson E Moore, Investigator 2/27/2025 OF THIS PAGE ~EMDort X ~r~t1E.M-. - ~:~~ir•~ FORM FDA 48 3 (09/08) PAGE 2 of3 PAGES PREVIOUS W mON OIJSO LllTE INSPECTIONAL OBSERVATIONS

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.

Eagle Pharma Outsourcing LLC’s FDA history

Argus HQ has recorded 1 total FDA action tied to Eagle Pharma Outsourcing 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 Eagle Pharma Outsourcing 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 Eagle Pharma Outsourcing 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 Eagle Pharma Outsourcing LLC: Form 483 with 5 Citations (February 27, 2025). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-eagle-pharma-outsourcing-llc-2025-02-27-3011688532

MLA

"FDA Inspects Eagle Pharma Outsourcing LLC: Form 483 with 5 Citations (February 27, 2025)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-eagle-pharma-outsourcing-llc-2025-02-27-3011688532.

Chicago

Argus HQ Research. "FDA Inspects Eagle Pharma Outsourcing LLC: Form 483 with 5 Citations (February 27, 2025)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-eagle-pharma-outsourcing-llc-2025-02-27-3011688532.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_eagle_pharma_outsourcing_llc_2025_02_27_3011688532_2025,
  title = {FDA Inspects Eagle Pharma Outsourcing LLC: Form 483 with 5 Citations (February 27, 2025)},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-eagle-pharma-outsourcing-llc-2025-02-27-3011688532},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗