Key facts
| Firm | Catalent Indiana LLC |
|---|---|
| FEI / inspection ID | 3005949964 |
| Inspection end date | July 14, 2025 |
| Citation count | 5 |
Citations explained
Observation 1 — Written records of investigations into the failme of a batch or any
Written records of investigations into the failme of a batch or any of its components to meet specific.ations do not always inclu de the conclusions and follow-up. Specifically, A. REC 831826 was initiated on J anu a1y 31, 2024, in response to Lot[(D) -(4)I, Project Code 4 (bJ < > [ being released without identification of two atypical extrinsic particles found during 100% manual visual inspection. One of the particles was identified as cat hair, while the second was not evaluated. You stated that only one representative pa1iicle is required to be identified if other similar defects are found, meaning no detennination into the source or impact of the second paiiicle was evaluated. Additionally, your investigation failed to detennine a root cause for the contamination, assess the potential impact to the rest of the lot, or evaluate whether si.milai· issues may have occu ned in upstream batches. The review of related deviations was limited to a one year time frame,.
Observation 2 — Procedures designed to prevent Inicrobiological contamination of drng products purpo1ting to be
Procedures designed to prevent Inicrobiological contamination of drng products purpo1ting to be sterile are not established, written and fo llowed. Specifically, A. Your media fi ll program does not include all high risk or critical interventions frequently observed. You categorize high risk or critical interventions, in part, via atypical unbracketed and atypical bracketed interventions. Your written media fill procedures do not require you to track and trend previous occurrences of these types of interventions for future inclusion into your media fill program. 1. You documented approximately 20 atypical unbracketed inte1ventions of[(b) (4) Ichange from 6/2023 through 6/2024. You failed to include this intervention into your media fill program. This in te1vention was document ed as the root cause of a failin g filling head s urface EM sample dated 8/26/2023. 2. You document ed approximately eight atypical unbracketed interventions of rod bar assembly replacement. You fail ed to simulate this intervention into your media fill program. This JOOH I _.
Observation 3 — Aseptic processing areas ai·e deficient regai·ding the system for monitoring environmental conditions
Aseptic processing areas ai·e deficient regai·ding the system for monitoring environmental conditions. Specifically, A. You do not pe1form direct surface monitoring of all of your filling heads. Instead, your written procedure specifically precludes direct contact of your filling head tips as it may render interpretation of results.difficult. Furthe1more, only[ ~) (4) ,__J is utilized for sampling. Syringe lineL ~(li(Yis not cmTently affected by this gap as you perfonned change control 982857 migrating from 6) (4) Isampling to( 15 ) (4}sampling May, 2025. This change was JOOH I Digitally signed SEE RE VERSE Joohi Cas telvetere, Investigato r byJOOHI CASTELV CASlELYmRE-S 7 /1 4 /2025 OF THIS PAGE Robert J. Ham, Investigat or )UERE -S ~~~fi~~ 4 Martin M. Kimani, Investigator Shannon L . Maisano, Investigator FORM FDA ~83 (09/08) PREVIOUS EDmON OBSOLETE
Observation 4 — Control procedures are not established which monitor the output and validate the
Control procedures are not established which monitor the output and validate the perfo1mance of those manufacturing processes that may be responsible for causing variability in the characteristics of in- process material and the drug product. Specifically, A. Limits are not cmTently established for individual defects found during 100% visual inspection operations; cmTently, they are only established for overall defect criticality categories (critical defects, major defects, minor defects). A-SOP-22-05-00 1, Manual Visual Inspection Using a [(6) (4) , requires action only if the overall catego1y defect rate is exceeded; meaning, atypical or othe1w ise unexplained increases of an individual defect type are not required to be investigated so long as the overall defect catego1y rate remains below limits. B. Your automated visual inspection (AVI) system categorizes defects as "cosmetic" or "paiticulate" and does not identify individual defect types (e.g., hair, glass, fiber) . Defect JOOHI Olg1tallYSigned0Y SEE REVERSE Joohi Cas telvetere, Investigato r JOOHI CASTE LVE c;,,sruVETUE -s 7 /1 4.
Observation 5 — Repo11s of analysis from component suppliers are accepted in lieu of testing
Repo11s of analysis from component suppliers are accepted in lieu of testing each component for confonnity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals. Specifically, your fnm relied on ce11ificate of analyses (COA) for incoming shipments of high-risk components (b) (4) an (b I (4) j from your suppliers. You have not tested each l ot and container of~ ) ( 4) ~H•i J upon receipt to detect and quantitate di ethylene glycol (DEG) and ethylene g!xcol J, G). (b) (4) and 41 tbH are used in t he manufacture of drng products including ~ (-4) , aKE}d(, b) (4), 7 rn the last 3 years your fnm has manufactured over t b} (4j lots of drng products containing 6 '(4) and ltil<•i for distribution. The products have any an expiration date of 1 to 4 years. JOOHI Oigitally ogned SEE REVERSE Jooh i.
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.
Catalent Indiana LLC’s FDA history
Argus HQ has recorded 2 total FDA actions tied to Catalent Indiana LLC: 0 warning letters, 0 recalls, 0 approval records, and 2 Form 483 inspection citations.
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 Catalent Indiana LLC had other FDA inspection citations?
- Yes. Argus HQ has recorded 2 total FDA actions tied to Catalent Indiana LLC, including 2 Form 483 inspection citations.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3005949964.
- 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 Catalent Indiana LLCCompiled 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 — Catalent Indiana LLC (July 14, 2025) — 5 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-catalent-indiana-llc-2025-07-14-3005949964
"FDA Form 483 — Catalent Indiana LLC (July 14, 2025) — 5 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-catalent-indiana-llc-2025-07-14-3005949964.
Argus HQ Research. "FDA Form 483 — Catalent Indiana LLC (July 14, 2025) — 5 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-catalent-indiana-llc-2025-07-14-3005949964.
@misc{argushq_argushq_ai_483_fda_483_catalent_indiana_llc_2025_07_14_3005949964_2025,
title = {FDA Form 483 — Catalent Indiana LLC (July 14, 2025) — 5 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-catalent-indiana-llc-2025-07-14-3005949964},
note = {Accessed: July 13, 2026}
}