Key facts
| Firm | Biocon Biologics Limited |
|---|---|
| FEI / inspection ID | 3015283245 |
| Inspection end date | September 3, 2025 |
| Citation count | 5 |
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 sanitation and facility maintenance procedures are not established or followed
Written sanitation and facility maintenance procedures are not established or followed. Specifically, A) Th~ '---,,------,----,.----·-- " .::..:..:_ ;process facility maintenance and cleanliness is inadequate for Grade C and D manufacturing areas. This includestli.e following deficiencies noted during the facility walkthrough on Au.,aust 26th., 2025: 4 <6>< 41·tanding puddle ~ithln the Grade C oom and adjacent =o tbe ~d to l. Li9.\!iill (b) <4 he Grade C ~ea, which houses the Grade BL (b:::,.ised for __________(b_H_,4}lrug substance batches. ,______. 2. A soiled mop labeled as "Grade D Area Cleanin " within the Grade C ><4 oom that adjacent to the Grade C batches. 5 rea, which houses the Grade B iJW __________________. g substance I,,ia<'}\ standing_p~ddle underneath the ~and 4 (bH4>area. stem w1thrn 4. Liquid standing puddle undemeath l,.____________~....J ank within _________. area.
Observation 2 — Written procedures are not established or followed for the cleaning and maintenance
Written procedures are not established or followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug substance. Specifically, 4),Jm August 29th, 2025, I observed visible rust spots within the Grade BC ,-rof-aminar Air Flow (LAF) ~ 1 and visible rust/removable m aterial on the outer LAF ,surfakes Qt.the Grade C environment. The LAF is used for m ctivities fo fl. (b)~P, ulk drug substance batches with a biobmden specification of 4 rur:}n1andl3actcnarnru:Iotoxms specification of NM1l 4 t':U/mg of protein. This included: 1. Visible[: ~ {Ust surrounding the seams and ridges of the ~ alve and knob stationed within the Grade B LAF 2. Visi~ ~st on the screw part within the Grade B side of the LAF view screen. 3. ~-~·e alant observed throughout the corner and edges of the Grade B LAF. 4. Visiblef~t observed within the edges of Grade B LAF 5. Visible,~ rust and brown material.
Observation 3 — There is a failure to thoroughly review any unexplained discrepancy and make
There is a failure to thoroughly review any unexplained discrepancy and make a record ofthe conclusions and follow-up. Out A) of Specification (OOS) Investigation Report No. 199753 was initiated on June to, 2024, due to OOS observed result: (bm fu/mL Limit NMT _5ful rnL) fo~ iTT4l-.ampling location description: ). ccording to the report, from the identified isolates (Ralstonia insidosa, Elizabethkingia miricola, Chry ,--se_o__b,_a_c-te-n'-·-'um indologenes) most probable cause could be current~ sanitization procedure not able to eliminate these isolates thus that ~uld lead to such localized ~ ad build up. Additionally, Due to the rust on the surface on th~ d~ ces might have probably led to potential ingress of the microbes on the iTT4l_fld which might have carried into the collected sample resulting into 0OS for the sampling points. In adciition, CAPA Number: 1,2.1318 was initiated as an additional control to reduce microbial ingress 192406 is logged to revise the SOP (Iii OP/0158 instruction to clean the hoses used fo.
Observation 4 — The responsibilities and procedures applicable to the quality control unit are not
The responsibilities and procedures applicable to the quality control unit are not in writing or fully followed. Specifically, A) Notification No: 1000387247, _....,. __ 26 Leak Test Failed, Dated: January 24, 2024 was raised due to leak test being conducted mc e!_e t\1es and having multiple failed results. The (b~ est of the complete system found that leak was od (b) 4 ·ide. A ___ ~aterial used for enoineering grade repair system for repairing and rebuilding machinery and equipment was applied on the~~~ith the failed leak test. However, there is no detailed impact assessment, risk analysis, cross-functional r~ approval, and post implementation verification for the effectiveness of the equipment repair operations. l!). During the inspection walkthrough on August 26 2025, I observed a crumbled up ster· • tionJ~~~l for 4 <6><4}lirectly on top of the ~-ontainer in Grade C (bTT oom oading area) wi'"'th_th ..,..e- f."'"o"'ll-ow_,.in_g_h,_an _ d.,.wr - itten details: ...___ _ Equipment Name: Sterilized: 24/08/20,_2_5----- Use Before: Sign.
Observation 5 — Laboratory Control Mechanisms are not established
Laboratory Control Mechanisms are not established. A) On September OI, 202 5, I observed that there is no final disposition record for one (I) out of! (b)(4 }nedia plates Ex ired On: August 31, 2025 labeled .las Environmental Monitoring (EM) sampling activities for ,..l____(b_H_.4!on August 12, 2025, AR No. (l>H4J\11ICR0-25-005 within the laboratory information management software. B) There is no notification or documented follow-up to multiple errors observed within QC Analytical Balances. 1bis consists of Analytical Balance NTP Server Error: "B ecause of the server down/network failure temporary." C) The following notification reader errors were displayed on the BET Kinetic software after bein° released for completion of Performance Qualification (PQ) on August 27, 2024: Error #0400 code at:I •(b,, According to the software manual: Error #0400: Carrier x-axis failed position verify. Error #:04 01 Filter wheel motor failed position verify. Errors 0400 and 040 l: indicate that an axis failed its Position Verify test. After moving a predefined number of.
Biocon Biologics Limited’s FDA history
Argus HQ has recorded 1 total FDA action tied to Biocon Biologics Limited: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- 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.
- 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 Biocon Biologics Limited 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.
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Related enforcement actions
Full FDA history for Biocon Biologics 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 Inspects Biocon Biologics Limited: Form 483 with 5 Citations (September 3, 2025). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-biocon-biologics-limited-2025-09-03-3015283245
"FDA Inspects Biocon Biologics Limited: Form 483 with 5 Citations (September 3, 2025)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-biocon-biologics-limited-2025-09-03-3015283245.
Argus HQ Research. "FDA Inspects Biocon Biologics Limited: Form 483 with 5 Citations (September 3, 2025)." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-biocon-biologics-limited-2025-09-03-3015283245.
@misc{argushq_argushq_ai_483_fda_483_biocon_biologics_limited_2025_09_03_3015283245_2025,
title = {FDA Inspects Biocon Biologics Limited: Form 483 with 5 Citations (September 3, 2025)},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-biocon-biologics-limited-2025-09-03-3015283245},
note = {Accessed: July 15, 2026}
}