Key facts
| Firm | Catalent Indiana LLC |
|---|---|
| FEI / inspection ID | 3005949964 |
| Inspection end date | April 24, 2026 |
| 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 — Written records of investigations into the failure of a batch or any
Written records of investigations into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up. Specifically, A. Extrins ic biological particulates (mammalian hair) have continued to be identified in finished sterile drug products. However, investigations into these events have not been completed in a timely manner and do not demonstrate that the root cause has been adequately identified and corrected. From approximately 08/30/2025 to prese nt , you have identified mammalian hair in finished units in at leas (( b) (4~ batches, including three identified in 2026, representing a recurring contamination issue (approximately l b) (4)batches out of [(b) (4) inspected in 2026). Probable root cause has been attributed to stopper components; however, this conclusion is based on an ongoing, aggregated trend investigation (REC 1093464), that was opened on 08/28/2025, and has not been substantiated through complete, batch specific investigations. All 4 (bl 1 > deviations are currently open..
Observation 2 — Control procedures are not established which monitor the output and validate the
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in- process material and the drug product. Specifically, A. Visual inspection methods have been implemented without adequately qualifying inspection sensitivity, defect detectability, or comparability between methods. For example: Your threshold (b) (4) studies failed to generate (b) (4) _______ across the full visible range of defects and failed to establish (b) (4) based on defect size at which defects become reliably detectable. Without establishing b 4 supported by _ b ___,_4__.. - you have not demonstrated that inspection sensitivity has been adequately qualified or that the visual inspection process is capable of consistently detecting and rejecting critical defects. Additionally, MVI studies were conducted using aggregated "particulate" defect categories that combined multiple particulate defect types (ex: glass, metal, rubber, fibers). Further, defect units were characterized by using broad size ranges rather than actual.
Observation 3 — 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 did not include adequate validation of the aseptic and sterilization processes. Specifically, EMPLOYEE($) SIGN...TUR!: SEE Joohi Castelve tere, Inves tigator 04/24/2026 REVERSE OF Robert J Ham , Investigator THIS PAGE Bra ndy N LePage , Investigator FORM FDA OJ (09JO&)
Observation 4 — The number of containers and amount of material taken from each container
The number of containers and amount of material taken from each container is not based upon appropriate criteria. Specifically, EMPl.OYEE(S) SIGNATUj:lE SEE Joohi Castelvetere, Investigator 04/24/2026 REVERSE OF Robert J Ham , Investigator THIS PAGE Brandy N LePage, Investigator
Observation 5 — Aseptic processing areas are deficient regarding the system for monitoring environmental conditions
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Specifically, Environmental monitoring is not always performed in response to interventions located and / or impacting critical surfaces. Examples include but are not limited to: M(4) ~ ., tools to include [(b) (4) ] (b) (4).
Observation 6 — The responsibilities and procedures applicable to the quaJity unit are not in
The responsibilities and procedures applicable to the quaJity unit are not in writing and fully followed. Specifically, You lack comprehensive trending analysis regarding your environmental monitoring program as well as your(b) (4) Iand (6) (4) decontamination (b) (4 )) program. Both programs lack adequate spatial analysis such as intra and inter location requirements over justified periods.
Observation 7 — Master production and control records lack complete manufacturing and control instructions
Master production and control records lack complete manufacturing and control instructions. EMPLOYEE($) SIGNAT\JRE SEE Jooh i Castelvetere , Invest i gator ~ 04/24/2026 REVERSE OF Robert J Ham , Investigator THIS PAGE Brandy N LePage , Invest i gator ll'tt'-Z_ FOR.\f F DA 483 (09/08) PREVIOUS EOrrtON OOSOl.J:rm INSPECTIONAL OBSERVATIONS PAOE 12 OF 14 PAGES
Observation 8 — 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, The (b) (4 ) Assembl Machine (§__q uiP-ment ID # (b) (4 )) is utilized to assemble and label sterile drug product (b) (4 ) into (b) (4 ) The firm assembles and labels the sterile drug roducts (b) (4 ) .----,, ~ and b 4 --------------------- on the b 4 assembly machine. .......,___.....__... The equipment performance qualification studies titled' (b) (4) Assembly Machine (System (b) (4 )) Performance Qualification Protocol Summary Report-VL-087 JUN2 l, VPQ-(b) (4) 000 l 9-S- VL-087JUN21, Client(b )(4) ," effective: 01/23/ 2023,' b 4 Assembly Machine S stem (o) (4) Performance Qualification Protocol Summary Report-VL-087JUN21 , Client..,.,(b..,..)-"(4_,_____ 6) (4) Addendum 11 , VP 6 4 -00019-S-VL-087JUN21-ADD1 l," effective: 01 / 27 /2026, and '( b) (4) Assembly and Labeling Machine (System (b) (4 )) Performance Qualification Protocol, A- VPQ-00061-P," effective:.
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
- Does this Form 483 mean Catalent Indiana 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.
- 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.
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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 (2026). Form 483 Record: Catalent Indiana LLC, April 24, 2026 — 8 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-catalent-indiana-llc-2026-04-24-3005949964
"Form 483 Record: Catalent Indiana LLC, April 24, 2026 — 8 Citations." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/483/fda-483-catalent-indiana-llc-2026-04-24-3005949964.
Argus HQ Research. "Form 483 Record: Catalent Indiana LLC, April 24, 2026 — 8 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-catalent-indiana-llc-2026-04-24-3005949964.
@misc{argushq_argushq_ai_483_fda_483_catalent_indiana_llc_2026_04_24_3005949964_2026,
title = {Form 483 Record: Catalent Indiana LLC, April 24, 2026 — 8 Citations},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-catalent-indiana-llc-2026-04-24-3005949964},
note = {Accessed: July 13, 2026}
}