Key facts
| Firm | Immacule Lifesciences Private Limited |
|---|---|
| FEI / inspection ID | 3014210753 |
| Inspection end date | September 18, 2025 |
| Citation count | 6 |
Citations explained
Observation 1 — 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 are not established and followed. 4 A. On September 10, 2025, we observed when the manufacturing operator transferred th\ Cb> C> 1LAF #3 lfrom the sterile room C6J C 4> into tha>¥ial filling room CbH4> the operator sanitized the top and upper sides of the '""~' LAF with-.~--- When wiping with the sanitizing aj ent, we 4 observef Jhe blue marker smear from the label located in the top front right side of the (bH > LAP onto the CbH4> surface. Subsequeri~~ >bJue ink residue was being transferred via the 4 contaminated wipe to other sections of the___LAFs front surface as the operator continued sanitizing. Additionall , on September 15, 2025, we were able to confirm the blue marker used is removable with the same Cb>c 4Y-- that is used in the filling room. This same marker is used for documenting the sampling ocations on e respective.
Observation 2 — 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. (b)(4) Aseptic processing operations conducted in filling Room...___μre deficient in design and controls to prevent microbiological contamination of sterile drug products. F_o r examnle. on September 8, 10 and 11 , 2025, we evaluated tlle (b) < 4> vial filling line (Equipment ID (bH4> ed to manufacture (bH 4> asepuc • fill, and temu·na11y sten.lized drug p rodnets t1lat are manufactured for tlle USA Market. TI1efollowing examples of poor filling room design, operators' .aseptic behavior, filling line assembly and smoke studies are not an exhaustive listing of what was observed: A. Your firm's aseptic vial filling line was observed to experience frequent (b) <4> interventions in tlle ISO 5 (Grade A) filling line area causing multiple line stoppages. Injection (TS), Batch (b) <4> During the filling of this batch, we ""o"c-" served .,..e inllerent interventions (Intervention.
Observation 3 — Aseptic processing areas are deficient regarding the system for monitoring environmental conditions
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. A. Your firm failed to conduct a scientific rationale for the (b) < 4y-i~on-viable particle counter (NVPC) locations ti>> < 4> within the aseptic core and ~one. the yial conveyor of your (b) (4) ~ial filling Line (Equipment ID (b) < 4> used to manufacture (b) < 4> aseptic fill, and terminally sterilized drug products that are manufactured for the USA market. Your Site Quality Head confirmed that your finn has not conducted a risk analysis to detennine whether the current locations of the isokinetic probes are meaningful. Additionally, your "General Validation Report of Worst Case study for Non-Viable Particle Counter Location" Document# MVP/GS/22/236/R0 1, approved on July 08, 2022, is inad~uatc as it failed to include and eyalnate_un to (b) <4J of track of the filling line where L (b> <4) product is (b) < 4 > (b)(4) r (b)(4) . ..__-~-- (b)(4) m--trans1tto tne ......---~_. This.
Observation 4 — 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 process. 1. Your aseptic process simulation is not representative of commercial batches release for the USA market. (b)(4) For example, yourfinn uses multiple vial sizes (e.g., (b) <4> • '"""".,...___ _- - S1·te .,,--ality"="'"-ad, your_,,,..._ .,.. ll,..._ _ its conm1ercial batches. Accordi.ng to_your "",...- Qu-,""- He -c-___ fi nn fio"cc ows J the "bracketing" approach to perform the (bJ (4J · imul ations of your commercial aseptic process. However, your firm did not provide a formal risk assessment that considers all potential contamination risk factors that could occur on the vial filling line to justify such a "bracketing'' approach. Moreover, during the period between January 2023 and June 2025, approximately~ of your USA released fill d ' r,> uw )( . 1 • • 1 • d d • batehes were e tn (4) -T ; 4pm via s..
Observation 5 — Appropriate controls were not exercised over computerized systems to ensure that changes
Appropriate controls were not exercised over computerized systems to ensure that changes in records are made only by authorized personnel. Your Quality Unit failed to establish sufficient controls, which prevents raw data and recipes/machine operational parameters from being manipulated in the LIMS, and SCADA systems, respectively. Specifically, we found that your SCADA system had user accounts with extensive administrative privileges, including the ability to modify/edit critical process parameteis and recipes without adequate oversight. Additionally, a similar deficiency was observed in LIMS, in which we found that certain users have the privilege and roles to editing or removing data and system parameters that do not pertain to the scope of their responsibilities. The systems mentioned below are not an exhaustive listing of the systems we observed within your facility, we observed the following deficiencies: SEE REVERSE OF THIS PAGE 8'P LOYEE(S) NMIE ANO TITLE (Frid« 7)J>OI OATEISSUEO Jose E Melendez, Investig11tor Damaris Y. Hernandez, Investigator September 18, 2025 Angelica M. Hernandez,.
Observation 6 — There is a failure to thoroughly review any unexplained discrepancy or the
There is a failure to thoroughly review any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. You failed to consistently conduct adequate laboratory investigations. Specifically, your investigations lack data supporting the assigned root cause(s). A. Investigation OOS/24/001 was initiated on April 11, 2024, due to an action-level result ofm :FU in volumetric air sampling during routine pre-environmental monitoring (EM) of the vial line (Equipme nt 4 ID Cb>< > ln preparation for line setup for CbH4> [nj cction USP CbH 4 > 4 mg, Batel! Cb>< > 'No USA distributerl cinurnrodacts). The recover~ was observed at the ISO-5 4 sampling location Cb>< > identified as Cb><• Cti> <4> he observed recovery was identified as Kocuria rosea, which is common liuman skin microflora. Additionally, recoveries were observed in the Grade B and Grade C areas for settle plate exposure, volumetric air.
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.
Immacule Lifesciences Private Limited’s FDA history
Argus HQ has recorded 1 total FDA action tied to Immacule Lifesciences Private Limited: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- Has Immacule Lifesciences Private Limited had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for Immacule Lifesciences Private Limited so far. Argus ingests new FDA records daily.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3014210753.
- 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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Related enforcement actions
Full FDA history for Immacule Lifesciences Private LimitedCompiled 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 — Immacule Lifesciences Private Limited (September 18, 2025) — 6 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-immacule-lifesciences-private-limited-2025-09-18-3014210753
"FDA Form 483 — Immacule Lifesciences Private Limited (September 18, 2025) — 6 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-immacule-lifesciences-private-limited-2025-09-18-3014210753.
Argus HQ Research. "FDA Form 483 — Immacule Lifesciences Private Limited (September 18, 2025) — 6 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-immacule-lifesciences-private-limited-2025-09-18-3014210753.
@misc{argushq_argushq_ai_483_fda_483_immacule_lifesciences_private_limited_2025_09_18_3014210753_2025,
title = {FDA Form 483 — Immacule Lifesciences Private Limited (September 18, 2025) — 6 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-immacule-lifesciences-private-limited-2025-09-18-3014210753},
note = {Accessed: July 13, 2026}
}