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 Aurobindo Pharma Limited, Unit VII had other FDA inspection citations?

This is the only FDA action Argus HQ has on file for Aurobindo Pharma Limited, Unit VII so far. Argus ingests new FDA records daily.

What is the FEI / inspection ID for this Form 483?

FEI / inspection ID: 3007373532.

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.

FDA Inspects Aurobindo Pharma Limited, Unit VII: Form 483 with 6 Citations (February 10, 2026)

Key facts

Firm	Aurobindo Pharma Limited, Unit VII
FEI / inspection ID	3007373532
Inspection end date	February 10, 2026
Citation count	6

In short: FDA inspected Aurobindo Pharma Limited, Unit VII in India and issued a Form 483 listing 6 inspectional observations following an inspection that concluded 2026-02-10. FDA records classify Aurobindo Pharma Limited, Unit VII as a finished drug product manufacturer. A Form 483 documents an investigator's findings at the close of an inspection under the Federal Food, Drug, and Cosmetic Act; it is not a final agency compliance determination. The observations on this page are drawn directly from the FDA-issued Form 483 record.

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 — Equipment and utensils are no1 cleaned at appropriate intervals to prevent th

Equipment and utensils are no1 cleaned at appropriate intervals to prevent th at would alt er the safety, identity, strength, quality or purity of th e drug product. Specifically, A. The (b><4> non-dedicated (b)(4) _,_·...--c-."- used in the manufacturing of (b)(4) (b)(4) drug products or t ,e US market at you r firm have not been a ppropriately cleaned since their instalfa(lon several years ago. For example, Ta ble I (b)(4) lD No.: in sta ll ati on da te Years s ince (b)(4) )uct not clea ned Guerlain Ulysse, [nvestigator OA~lss.EO SEE REVERSE Pracik S. Upadhyay, DD C Inves ti gator 02/10/2026 OF THIS PAGE Nibin Varghese, fn vesti oator .... _,.. " .. •"'"''""'•, n l :SS P(CT IO N. \ L OBSER\',\ T IO N Page I of 27

Observation 2 — Master production and control records lack complete manufacturing and control instructions, sampling

Master production and control records lack complete manufacturing and control instructions, sampling and testing procedures. Specifically, O,HEISSVEO Guerlain Ulysse, Investigator _C,U-- 02fl 0/2026 SEE REVERSE Pratik S. Upadhyay, ODC lnvestigato~fSv OF THIS PAGE Nibin Varghese, Investigator 'f'l' fORMfDA -IH l«t- \lo';,H XTll"oNo,<-S, )I 1-.n-. INS P[CTIONA L OBSERVATION Page 14of27

Observation 3 — Complaints records arc deficient in that they do not include the findi

Complaints records arc deficient in that they do not include the findi ngs of the investigation and follow u p. Guerlain Ulysse, Investigator C. V, OATEISSl.£0 SEE REVERSE Pratik S. Upadhyay, DD C In vestig ator {!£1.li 02/ I 0/20 26 OF THIS PAGE Nibin Va rghese, Investigator ~..J FOR\t FDA ~SJ ,,.,_,,," ""'""'""'' _..,' INSP ECTIONAL O8S ERV..\Tl01' Page 15of27

Observation 4 — There is a fai lure to thoroughly review any unexplained discrepancy and

There is a fai lure 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, OATE ISSVE.D Guerlain Ulysse, Investigator (;..u., SEE REVERSE 02/10/ 2026 Pratik S. Upadhyay, DDC Investigator~JOF THIS PAGE Nibin Varghese, Investigator N• FORM f0A •SJ '""' ""'' "'""~"""" n rNSP£CTlON.\L OBSERVATION Page l8of27

Observation 5 — Laboratory records are deficient in that they do n ot include a

Laboratory records are deficient in that they do n ot include a compl ete record of all data obtained during t es ting. Specifica I ly. A. On Janua 28, 2026, during the walkthrough in s pection at your microbio logy laboratory in th e(b~ (bH4l Block H4 it was observed that yo ur Assistant Manager for M icrobiology was signing mul tiple documents with dates th at did not correspond to the actual date of s ignature. Review of these documents revealed that none of the documents had the date of Janu ary 28, 202 6, despite being s igned on ch at day. All th e documents had dates of Janua ry 27, 2026, or earlier. On muhiple occasions, your Guerlain Ulysse, Investigator (),. lJ ., 0 A11:ISSl.£0 SEE REVERSE Pracik S . Upadhyay, DOC Investigato r~ 02/ 10/ 2026 OF THIS PAGE Nibin V arghese, Investigator ~ • Page 23 of27 4

Observation 6 — Established laboratory cont rol mechanisms a re not fo ll owed

Established laboratory cont rol mechanisms a re not fo ll owed. S pecifi ca lly, During the walkthrough inspection of the Cb)(4) 'B lock (b)(4) multiple incidents were obs erved wh'ere e mploy ees were not follow ing the written procedures. Thrs rnc rd dcs, but is not limited to: A . According to sect i on 4 .3 of your written proced ure G TP No GTP 151-07: DescripJion/CharacJeristics Version 1.0. 0. 0. EffecJive Date: December 23, 2021, appearance testing sho uld be conducted by Cb><4J and observ ing th e details in(b)(4) agains tCb><4> ~ackgrounds. However, on Janu ary 28, 2026, a n anal yst from the ><4>· ...-...-- ---.,-- Block (b) 4> conducted a ppearance testing b m er ely obse rvin g tablets through blister packa ging during stability testing of oot4l Cb><4> Tablet s US P.Cb>< __ mg 4 :ng,o,) 4} mg). Batch Nu m ber li "'"A' Fu rt her investigation r eveal ed.

Aurobindo Pharma Limited, Unit VII’s FDA history

Argus HQ has recorded 1 total FDA action tied to Aurobindo Pharma Limited, Unit VII: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

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 Aurobindo Pharma Limited, Unit VII had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for Aurobindo Pharma Limited, Unit VII so far. Argus ingests new FDA records daily.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3007373532.
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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Full FDA history for Aurobindo Pharma Limited, Unit VII

Compiled 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.

APA

Argus HQ Research (2026). FDA Inspects Aurobindo Pharma Limited, Unit VII: Form 483 with 6 Citations (February 10, 2026). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-aurobindo-pharma-limited-unit-vii-2026-02-10-3007373532

MLA

"FDA Inspects Aurobindo Pharma Limited, Unit VII: Form 483 with 6 Citations (February 10, 2026)." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/483/fda-483-aurobindo-pharma-limited-unit-vii-2026-02-10-3007373532.

Chicago

Argus HQ Research. "FDA Inspects Aurobindo Pharma Limited, Unit VII: Form 483 with 6 Citations (February 10, 2026)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-aurobindo-pharma-limited-unit-vii-2026-02-10-3007373532.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_aurobindo_pharma_limited_unit_vii_2026_02_10_3007373532_2026,
  title = {FDA Inspects Aurobindo Pharma Limited, Unit VII: Form 483 with 6 Citations (February 10, 2026)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-aurobindo-pharma-limited-unit-vii-2026-02-10-3007373532},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗