Key facts
| Firm | Apotex Inc. |
|---|---|
| FEI / inspection ID | 3001617666 |
| Inspection end date | May 9, 2025 |
| Citation count | 8 |
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 ah-eady distribute d. 1. On April 30, 2025, (bTC4l leak tests were attempted onl (b114)Filling Line ~ and all of them failed. The (b>C1is used fo r aseptic filling of l (b>C4j products fo r the US market. Subsequent! (b'< 4j leak testing on May 1, 2025, identified 34 different locations around the l (b)l-41 that were leaking. The identification of leaking locations was not thoroughly documented.1 (b1r4tests are not documented, but should have been performed at the start of the I (b)l, cycles completed between ~ (bTC, There has been no investigation into 1 how these tests passed when subsequent l•H 4 1leak testing and (b)l4 leak testing identified at least 34 leaking locations. Previous identifications ofl (bT'i leaks did not include investigations.
Observation 2 — Equipment and utensils are not cleaned and maintained at appropriate intervals to
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identi ty, strength, quality or purity of the diug product. I.On M[ 1,_2~25, during filling of (b)1 4 Spray batch (b)l4l (US market) on filling line l1>J<4l ------- ---- a. There was a build-up of unidentified (br( 4 paiticles on equipment surfaces beginning ---- SEE REVERSE OF THIS PAGE
Observation 3 — Written procedures are not establish ed that describe the tests and exaininations
Written procedures are not establish ed that describe the tests and exaininations to be conduct ed on appropriate samples of in-process materials of each batch. 1. Your fum does not per fo rm 100% visual inspection on filled bottles of j Cb>1 4 Jsolutions manufactured on your ~ Tr 4 l line. This line fills I ·CbTC 4 ~bottles fo r some drng products, SEE REVERSE OF THIS PAGE EMPLOYEE(S) SI GNATURE Jus t in A Boyd, Inves t iga t or Wayne D Mcgra t h, Inves t iga t or DATE ISSUED 5/9/2025 PAGE 15 of24 PAGES FORM FDA ~83 (09/ 08) PREVIOUS EDmON OBSOLEJE INS PEC TIONAL OBSERVATIONS
Observation 4 — Procedures designed to prevent microbiological contamination of diug products pmp o1ting to
Procedures designed to prevent microbiological contamination of diug products pmp o1ting to be sterile did not inclu de adequate validation of the aseptic process. 1. Your fnm does not ll!_cubate all integral units during m edia fills. For example, during media fill, 4 batch number Cb>< you per fo1med fill volume checks on (b 1141 units which were initially integral, but an employee opened and emptied the units to per fo1m fill volume checks. Your fnm did not incubate approximately WCl units used for fill volume checks for each m edia fill per fo1med in the past three years. 2. On our CbT solution line Cb)l4l while conductin Inte1vention CbT, (b) j Due to laclc of1i1hng operations durmg the --------------------- inspection, we obse1ved this process in a smoke study video per fo1med in June 2023. Your Specialist of Quality Validation stated blocking the first air was required during this inte1vention during commercial manufacturing. Your approved inte1ventions fo r CbT<4l procedure,.
Observation 5 — Aseptic processing areas are de fi cient regarding systems for maintaining any
Aseptic processing areas are de fi cient regarding systems for maintaining any equipment u sed to control the aseptic conditions. 1. There is no non-viable particle monitoring inside the aseptic fillin g! (bY{-4) conducted near the (bY{ 4 j bowl, or near the l C6Tc1 of the \UJ\..i (bTC4l 1 d h fill . h. There is onl{ (bn 4 j non-viable paiticle counter inside th ocate near t e 1 mi mac me. 4 On April 29, 2025, during set-up forl (b)( Solution batchl CbT( 4kus submission batch), the probe was angled away from the filling machine. 2. There is no viable monitorin~perfo1med fr om the end of set -llr to the stait of fillin g. During this • h d (b1 "' 1 • 1 d. b 1 d (bTC4l d d time t ere ai·e expose c osures me u mg ott es an ·1 an pro uct contact 4 surfaces like I l•H Inter ventions for.
Observation 6 — Procedures describing the handling of written and oral complaints related to diug
Procedures describing the handling of written and oral complaints related to diug products are. 1. Your fnm has not implemented adequate corrective and preventive actions (CAPAs) for approximately 492 market complaints related to hard to open bottlee~ of CbTC 4 di11g products in the Qast three years. The oroducts include, but are not limited to, Cbf~ CbH4 • ~~1 .I Cb1l4l • Cb CbH"j solution ~ 4~% ·i so lution C4 %, andI4 4 1 Cb>< solution Cb < % . On 01 September 2022, your fnm OQe ned a CAPA (PR ID 1341808) to addi·e s~•H4l variation on your CbH 4j filling line Cb 1 14J and it was closed on 12 September 20 23 a er your fnm optimized th~process and :_:jparameters. Howevec om) fnm did not implement an upper 1• • £ (b)(4l h \U/\~ 1· d nl b 1 • h (bY{4 b 1 h 1 1· • f [] 1m1t or ·1 on t e.
Observation 7 — Your fnm failed to establish adequate written procedures for production and process
Your fnm failed to establish adequate written procedures for production and process controls designed to assure that the diu g products have the identity, strength, purity, and quality that they ai·e purpoited or represented to possess. SEE REVERSE OF THIS PAGE
Observation 8 — Establish ed sampling plans and test procedures are n ot fo llowed
Establish ed sampling plans and test procedures are n ot fo llowed and documented at the time of per fo1mance. 1. On 01 May 2025, during d (bH4 leak test of the (bTC4lon the (b)l4l line, the was fluctuating between (bH4 and (bH4l leak test procedure, number_S_O_P__P_R- 4 070.004-R, instructs the CtiJC to be ____ to (bTC4l in section 7.8. In 4 addition, we observed an Qperator holding th~ (bH 4j on the frames of t1!e Ctirc fo r approximately (b)(41 per location, but your procedure requires (b)C4l of contact time fo r each location in section 7.12. 2. Documentation of environmental monitoring of the aseptic filling (b)l1 is not documented accurately and contemporaneously. The sampling personnel collect all samples from (bTC4l consecutively before making any documentation. The documentation they eventually enter into LIMS contains specific times of sampling that were not recorded at the time of sampling. d. On April 30, 2025, at 4:19 pm the operator was observed.
Frequently asked questions
- 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 Apotex Inc. 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.
- 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.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3001617666.
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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 — Apotex Inc. (May 9, 2025) — 8 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-apotex-inc-2025-05-09-3001617666
"FDA Form 483 — Apotex Inc. (May 9, 2025) — 8 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-apotex-inc-2025-05-09-3001617666.
Argus HQ Research. "FDA Form 483 — Apotex Inc. (May 9, 2025) — 8 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-apotex-inc-2025-05-09-3001617666.
@misc{argushq_argushq_ai_483_fda_483_apotex_inc_2025_05_09_3001617666_2025,
title = {FDA Form 483 — Apotex Inc. (May 9, 2025) — 8 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-apotex-inc-2025-05-09-3001617666},
note = {Accessed: July 15, 2026}
}