Has NerPharMa S.r.l. had other FDA inspection citations?

This is the only FDA action Argus HQ has on file for NerPharMa S.r.l. so far. Argus ingests new FDA records daily.

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

FEI / inspection ID: 3004762406.

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.

Form 483 Record: NerPharMa S.r.l., June 27, 2025

Key facts

Firm	NerPharMa S.r.l.
FEI / inspection ID	3004762406
Inspection end date	June 27, 2025
Citation count	1

In short: FDA inspected NerPharMa S.r.l. in Italy and issued a Form 483 listing 1 inspectional observation following an inspection that concluded 2025-06-27. FDA records classify NerPharMa S.r.l. as a drug manufacturer. 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 — Procedures designed to prevent microbiological contamination of diug products pmpo1ting to be

Procedures designed to prevent microbiological contamination of diug products pmpo1ting to be sterile did not include adequate validation of the aseptic and sterilization process. Specifically, A) Inherent and conective interventions and the times/durations in which they occur, are not always documented within batch production records as required by procedure TB021, Injectables: Allowed Interventions During Aseptic Processing on [(6) (fil Line, Version: 3. There is no assurance the maximum number of times and durations they are perfo1med during routine production are accurately simulated during media fills. B) Media fills are per f01m ed using a split batch approach, where some units of the batch are transferred to the[(6) (4) I (to represent the i t>) (4t __J process) and the remaining vials are fill ed as [(b) {4) ·I This media fill approach is not representative of routine operations. C) During Aseptic Process Simulations, Step (b) (41states to simulate the sampling "without taking any vials from the filling line". However, during.

NerPharMa S.r.l.’s FDA history

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

Frequently asked questions

Has NerPharMa S.r.l. had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for NerPharMa S.r.l. so far. Argus ingests new FDA records daily.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3004762406.
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.

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Full FDA history for NerPharMa S.r.l.

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). Form 483 Record: NerPharMa S.r.l., June 27, 2025 — 1 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-nerpharma-s-r-l-2025-06-27-3004762406

MLA

"Form 483 Record: NerPharMa S.r.l., June 27, 2025 — 1 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-nerpharma-s-r-l-2025-06-27-3004762406.

Chicago

Argus HQ Research. "Form 483 Record: NerPharMa S.r.l., June 27, 2025 — 1 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-nerpharma-s-r-l-2025-06-27-3004762406.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_nerpharma_s_r_l_2025_06_27_3004762406_2025,
  title = {Form 483 Record: NerPharMa S.r.l., June 27, 2025 — 1 Citations},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-nerpharma-s-r-l-2025-06-27-3004762406},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗