Key facts
| Firm | Aurobindo Pharma Ltd. Unit-XII |
|---|---|
| FEI / inspection ID | 3004446312 |
| Inspection end date | September 5, 2025 |
| Citation count | 8 |
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, or did not include adequate validation of the aseptic process. Specifically, Your firm' (bY{4~e_man ufacture sterile drug products tor the U.~. market j! CbH 1 4 1111 Imes are equ1ppea w1tn ,; ~testricted Access Barrier System). During the inspe ction, l (EL) observed the following. A. Th~ ~\ABS design principle and purpose are not adequately followed to prevent potential . . micro ial contamination of drug products purporting to be sterile. Specifically, excessive (bY{4 (b)l4':nterventions were perfonned that pose significant risks to product quality. For example, a) Pe[ CbT( Line,lliH4 of the'.(1,1141,Grade A intervention types ard CbTOO·nterventions. Review ofth~~~ {6)l niection batch processing records (BPRRs) for U .S. batche. CbTCl revealed that I Cb><4 interventions were oerformed rest4plect1vely due to either a 1 (b)(4~ . h . . d {6)(4 lack ofl r not usmg t e existing DATE ISSUED EM"'-OVEE(S) SIGMII.
Observation 2 — Aseptic processing area are deficient regarding the system for monitoring environmental conditions
Aseptic processing area are deficient regarding the system for monitoring environmental conditions. Specifically, Elll'!O'fEE(SJI/AMeJINOTITIE(Prirltit >~ , lE ISSUEO 09/05/2025 liMPI.OYEE(SJSl!lNAIIJRI! ✓~ SEE Eileen A. Liu, Investigator 1tt6~ REVERSE OF Joseph A. Piechocki, Investigator THIS PAGE Claudia Perez-Kasmarski, Investigator FORM FDA 40 (09/00) PR.fi'VIOUS EOO K»l 08."lOL.ETF.
Observation 3 — 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 its components to meet any of its specifications whether or not the batch has been already distributed. Specifically, EMPLOVEEtS)SIGNATIJRE EMPt.OYEc(S) ~At€ AND un.e {PMl orlYJ)f) DATE ISSUED , .. 09/05/2025 SEE Eileen A. Liu, Investigator ~ REVERSE OF Joseph A. Piuhocki, Investigator THIS PAGE Claudia Perez-Kasmarski, Investigator FO RM FOA 413 (09/06) PRBVLOUS EOO'ION OOSOt.61'£ INSPECTIONALOBSERVATIONS PAOElOF JSPAGES
Observation 4 — Your firm failed to e..'itab lish adequate written procedures for production and
Your firm failed to e..'itab lish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. Specifically, A. Process validations do not ensure critical parameters are challenged and validated ranges are not incorporated into batch records. For example: b. Samples were obtained from th ___ •ff41during the process validation summarized in FU12-PPQ-R-0230 from (b)(4) (b)l4 ~There • f I ---- (bTf4 i • h w.;t..s..n<l.iestrA\!.in~ ese samR es, nor was there _____,testmg 01 ____ __. n t e ____ o ensure! (b>14 j ccor mg to the validation protocol, over (b)(~ofthe drug substance may lead to dissolution problems, and the (bT is..__......cons, ered a critical step. c. The batch production record implemented based on the above process validation incorporated a tota (b)l4' ime of NLT (b)--C-0 nd allows 2 CtiTC 4 ~of EMP'-OYEE(S)SIONATURE EMPLOYEE(S)NAAIE ANO TITLE /-orTy,,e) OATE ISSUED 09/05/2025.
Observation 5 — Written production and process control procedures are not followed in the execution
Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance. Specifically, (b)"{,4 A. I quipment parameter changes are not always recorded and there are no established procedures related to the appropriate checks required to be conducted when parameters are changed after set-up. For example, the following batch records were reviewed in which parameters were changed, and no procedures were provided which indicated the in-process checks required to be conducted: . lbT(4l r (bY{t a) Dunn~the manufac.tu~ ·~ U'..aluets..Jl..S.l!I (6) '.4~ (b)( ¼ (b)l4l lrg Batch ·,atter setup was completed, the I i (b)(4fe re changed from the original a,, roved set-un (6)"{41 parameters according to the operating history obtained from theI equipment. The batch record did not indicate these changes. olln ,ssu~t> EMPf.OYEl;(SJ SrGNATURE EMPI.OYfE(SJNANEANOnTU!(PMotl)op,) 09/05/2025 SEE Eileen A. Liu, Investigator REVERSE OF Joseph A. Piechocki, Investigator THIS PAGE {!;~ Claudia Perez-Kasmarski, Investigator ~¢ FORM.
Observation 6 — Equipment and utensils are not cleaned at appropriate intervals to prevent contamination
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. Specifically, A. The campaign length cleaning studies conducted for CbJl4l nd CbT(4J equipment to establish the number of days or number of batches before a ype c eanmg nee s to be performed are not scientifically justified or defined. For example: a. ______ CbT R/SD Z1<4'p8 (within ,.,. •which is used fort e CbH4 of Cb>C4 sed in the manutacture ot]_, ___,_________ Cb><4t[ablets USP, the number of batches execute between Type Ccleaning ranged rroin'CbT<4'patches. The campaign length study used~to support the number of days/batches within a campaign challen ed ~. the (b>C4'~owever did not document the rationale for not including the CbH4 CbH4>wiffim the room. SEE REVERSE OF THIS PAGE fOR/.1 FDA ..J (O?lllt) PAGES EMPl.OYEE(SJ SIGNATURE EMPLOYEE(S) NAME AND TITLI: (Pld or Type) 09/05/2025 Eileen A. Liu, Investigator Joseph A. Piechocki, Investigator Claudia.
Observation 7 — Buildings used in the manufacturing, processing, packing, and holding of a drug
Buildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained in a good state of repair. Specifically, A. On 27Au 2025 during the walkthrough ins ection of the Packi ng Material Storage Area .....,__....,.___°'_n_,"M'arehouse lo cate<J; Cb)l4' fthe warehouse building were ___ observed in a state of disrepair. I (CPK o serv ea y, corroded, and perforated ceilings and rainwa te r seeping through the shipping doors and ceiling tiles. As I (CPK) walked throughout the storage, I (CPK) observed puddles of water accumulated and a plastic bag collecting rainwater near entry doorways. In add it ion , rainwater from leaks was observed in the following areas: a. CbT<4?J>ack ing Materials Storage b. Cb)l acking Materials Storage ,..___________, EMPLOV'EE(S) SIGNATURE EMPLOVEE(S) NAME ANO TITLE (Prinl r,1 Typa) 09/05/2025 Eileen A. Liu, Investigator SEE Joseph A. Piechocki, Investigator REVERSE OF Claudia Perez-Kasmarski, Investigator THIS PAGE FORM FDA -W (09/tlll) nu,..v 1ous EDfnON OOSOLlrtE: INSPECTIONA LO.
Observation 8 — The responsibilities and procedures applicable to the quality control unit are not
The responsibilities and procedures applicable to the quality control unit are not fully followed. Specifically, A. During the review of the cleaning and sanitation of the (6yt.\J ystems, passivation report _ (b)( 4 of storage tanks and loop distribution system performed on 08Dec2024 shows that the (b1r4k,as and out of specification. According to SOP FU12- EN- CLN-008, the loop must be.,_______, OAl E~ EMAO>'EE/S/ SIGN,UURE E MPLOYEE(S) NAAIE AND TITLC /Pt•N ot T'ypeJ 09/ 05/ 2025 Eileen A. Liu, Investigator SEE Joseph A. Piechocki, Investigator REVERSE OF Claudia Perez-Kasmarski, Investigator THIS PAGE
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.
Aurobindo Pharma Ltd. Unit-XII’s FDA history
Argus HQ has recorded 1 total FDA action tied to Aurobindo Pharma Ltd. Unit-XII: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3004446312.
- 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.
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Related enforcement actions
Full FDA history for Aurobindo Pharma Ltd. Unit-XIICompiled 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 — Aurobindo Pharma Ltd. Unit-XII (September 5, 2025) — 8 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-aurobindo-pharma-ltd-unit-xii-2025-09-05-3004446312
"FDA Form 483 — Aurobindo Pharma Ltd. Unit-XII (September 5, 2025) — 8 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-aurobindo-pharma-ltd-unit-xii-2025-09-05-3004446312.
Argus HQ Research. "FDA Form 483 — Aurobindo Pharma Ltd. Unit-XII (September 5, 2025) — 8 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-aurobindo-pharma-ltd-unit-xii-2025-09-05-3004446312.
@misc{argushq_argushq_ai_483_fda_483_aurobindo_pharma_ltd_unit_xii_2025_09_05_3004446312_2025,
title = {FDA Form 483 — Aurobindo Pharma Ltd. Unit-XII (September 5, 2025) — 8 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-aurobindo-pharma-ltd-unit-xii-2025-09-05-3004446312},
note = {Accessed: July 13, 2026}
}