Key facts
| Firm | Patheon Italia S.p.A. |
|---|---|
| FEI / inspection ID | 3004110157 |
| Inspection end date | February 18, 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 — : Quality Unit (QU) oversight over the manufacturing process is inadequate
: Quality Unit (QU) oversight over the manufacturing process is inadequate. Specifically, A. Written records of investigations into unexplained d iscrepancies, the failure of a batch or any of its components to meet specifications, do not always include appropriate documentation, conclusions, and follow-up. For example, 4> a. No deviation reco rd was opened for the use of an unqualified standard and procedure for rein spection off<bR 7 ~~ ~ ~- lot of1 ( IO0o/c VJ) on 11 September 2024. The same lot was subjected to another 100%c4> NI (second reinspection) between 25 - 27 September 2024. No deviation was opened for exceedance of the maximum number 4 of reinspections CbH > ,allowed per your procedure SOP-000042781, "Procedura generale di ispezione visiva", 1 ver. 19. b. You were informed by your client on 29 January 2024 that the validated filling time duration for CbH"~ hould ,:;>e reduced to that validated via'(1>)(4) _JTi edia fills, i. e.,I CbHil> !Although this time was.
Observation 2 — : Failure to establish process controls and test in g designed to
: Failure to establish process controls and test in g designed to assure that the drug products you manufacture have the identity, strength, quality and purity that it purports or is represented to possess. Specifically, a. Your firm fai led to adequately validate and control the stoppering process for (bJC4J Specifically, . . ' . '(6r(4) No engmeermg runs were perfonned pnor to lish the critical process para (bH.il> necessary to ensure that he specification of N were manufactured at a __.,...., (bH4> ..----. ith an alarm set ai 4 bulk.(bH4>-i.i nits were sent to the (bH4> of which (bX > units(b)<4Y7 1o) failed the check. Your QR 847868 deviation mvestigation into the matter concluded that frequent stoppages during the batch led to an increased (b)<4 >~ riability. However, this potential source of variab il ity of the CPP could 0000 . ~00 not be confirmed as the________--__ _. as not recorded m the executed MBR or ,batch re~ort for.
Observation 3 — : Procedures designed to prevent microbiological contamination of drug product purporting to
: Procedures designed to prevent microbiological contamination of drug product purporting to be sterile are not fully established or followed. Specifically, (b)(4) a. Your manufacturing process for fill line .f inclmiP~(b)(4) U.S. commercial manufacture of (b)(4) asiptic process simulation (APSfrn me spec1t1ea tlll Imes, you a1leo to ref.lace <bl(4l fo r the <b><4l ystem and as a (b)(4) ( on fillline <b><4) is used as a (b)(.., only). The APS is not representative of yo ur commercial manufactur1ng process as you failed to ha vethc (bH4) system active during media tills. Allhou~h Y.2l' recognized the deficiency in August 2023 and the opened CAPA to include the addhion of <b><4l 4 (b){ to each of the specified fill lines for replacement of (bJ(4) for the, <b)< > system and <b><4> n the APS, its implementation is currently scheduled for January 2026. You fai led to conduct co rrecfive action in a timely manner. b. Qualification and periodic requalification of aseptic operators.
Observation 4 — : Your program for the visual inspection of sterih drug products does
: Your program for the visual inspection of sterih drug products does not provide adequate assurance that finished products manufactured at your facility possess their purported quality attributes, including that they are essentially free from particulate matter. This is evidenced by: A. Training and qualification of personnel performing CbH4~ inspection 'lb)<4>v1) of small volume parenteral 4 products filled in Cb><4> glass vials ___ Cb>< > ____....,are inadequate. Specifically, a. Per SOP-000042781 , "Pro~edura generale di ispezione visive", ver. 19, training of visual inspectors consists of theoretical training on visual~~ VI-related procedures, review of the photo library of defects, and on the job training with a qualified inspector. You do not have training visual inspection sets for familiarization of inspectors with the defects they may encounter while performing ~~\I I and you failed to provide evidence that the required DATE ISSUED EMPLOYEE(S) NAME AND TITLE (Print or Type) Wayne Seifert, Senior Regulatory Specialist SEE REVERSE Ekaterina Allen, Pharmaceutical Scientist OFTH/S 02/18/2025.
Observation 5 — : Your rogram for the environmental control of classified areas, including critical
: Your rogram for the environmental control of classified areas, including critical supporting area for the Grade A Cb><-O does not provide assurance of your ability to adequately clean and/or disinfect your classified areas and detect levels of their microbial contamination. Specifically, A. Your routine environmental monitoring (EM) program is not optimized for detection of environmental contaminants and monitoring the state of your manufacturing facility. For example, floor viable surface samplin g_ in a.II cJassifi&i?iirea s_of..t be (b)(4) facility is limited to sampling points [ s_______(b_)(_ 4>__________ alls of the facility are not routinely monitored. B. Your procedures for cleaning of the classified areas are either deficient or not followed. For example, per SOP-00382550,' Cb)<4 >7:> ulizia locali classi Ce D Repa110 (b)(-4> ver.4, ,'lb><4> cleaning" should be performed 16 4 :>,~~ Jnthe absence of production activities and >< > cleaning with sponc1dal should be erformed Cb><4> ~ According to the cleaning log Cb)<4 >J 49/02-10 (filling room (bR4> and.
Observation 6 — : EMPLOYEE(S) NAME AND TITLE (Print or Type) DATE ISSUED SEE Wayne
: EMPLOYEE(S) NAME AND TITLE (Print or Type) DATE ISSUED SEE Wayne Seifert, Senior Regulatory Specialist REVERSE OF THIS Ekaterina Allen, Pharmaceutical Scientist 02/18/2025 PAGE
Patheon Italia S.p.A.’s FDA history
Argus HQ has recorded 1 total FDA action tied to Patheon Italia S.p.A.: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- What happens after a Form 483 is issued?
- The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.
- Has Patheon Italia S.p.A. had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for Patheon Italia S.p.A. so far. Argus ingests new FDA records daily.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3004110157.
- 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.
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Related enforcement actions
Full FDA history for Patheon Italia S.p.A.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.
Argus HQ Research (2025). FDA Form 483 — Patheon Italia S.p.A. (February 18, 2025) — 6 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-patheon-italia-s-p-a-2025-02-18-3004110157
"FDA Form 483 — Patheon Italia S.p.A. (February 18, 2025) — 6 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-patheon-italia-s-p-a-2025-02-18-3004110157.
Argus HQ Research. "FDA Form 483 — Patheon Italia S.p.A. (February 18, 2025) — 6 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-patheon-italia-s-p-a-2025-02-18-3004110157.
@misc{argushq_argushq_ai_483_fda_483_patheon_italia_s_p_a_2025_02_18_3004110157_2025,
title = {FDA Form 483 — Patheon Italia S.p.A. (February 18, 2025) — 6 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-patheon-italia-s-p-a-2025-02-18-3004110157},
note = {Accessed: July 15, 2026}
}