Key facts
| Firm | Dabur India Limited |
|---|---|
| FEI / inspection ID | 3001413302 |
| Inspection end date | January 16, 2026 |
| Citation count | 6 |
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 — The quality control unit lacks authority to review production records to assure
The quality control unit lacks authority to review production records to assure that no e1Tors have occu1Ted and fully investigate e1Tors that have occmTed. During the inspection, yo ur fnm' s laborato1y operations were found to have signifi cant deficiencies in data integrity, record maintenance, and analytical controls. Your quality control unit did not adequately oversee these operations to prevent systematic violations. Specifically: A) Inaccurate Laboratory Data: Review of records of over J~H4> fi nished product microbiology samples tested over I (b)< 4> revealed that 100% of the results were reported as "<10" (zero colonies) in laborato1y records. However, during the inspection on Januaiy 12, 2026, investigator observed the presence of colonies on multiple plates during plate reading activities including two plates that were TNTC (too numerous to count) for the diu g product ~H4> I ~ )(4) I which was inconsistent with the documented tren d. Your fnm peifo1m s microbial release testing for US mai·keted OTC products including.
Observation 2 — Procedures fo r the cleaning and maintenance of equipment ai·e deficient regai·ding
Procedures fo r the cleaning and maintenance of equipment ai·e deficient regai·ding the protection of clean equipment from contamination prior to use. Specifically, your cleaning validation program fo r non-dedicated manufacturing equipment, used for multiple diug products, is inadequate. SEE REVERSE OF THIS PAGE
Observation 3 — Dmg product production and control records, are not reviewed and approved by
Dmg product production and control records, are not reviewed and approved by the quality control unit to dete1mine compliance with all es ta blished, approved written procedures before a batch is release d or distributed. Specifically, During the inspection, batch manufacturing and analytical records fo r (b) batches across (b) products were (b,C4) ••• • •• reviewed : The following deficiencies were observed: A) Analytical data fo r residue on ignition and melting range tests recorded in BMRs and COAs did not match the co ITesponding entries in (bH4> analytical data books for (bH 4 > SEE REVERSE OF THIS PAGE EMPLOYEE(S) SI GNATURE Rafeeq A Habeeb, I nves t iga t or DATE ISSUED 1 / 1 6/2026 FORM FDA ~83 (09/ 08) PAGE 5of9 PAGES PREVIOUS EDmON OBSOLEJE INS PEC TIONAL OB SERVATIONS
Observation 4 — Written procedures are not establish ed and fo llowed fo r evaluations
Written procedures are not establish ed and fo llowed fo r evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected. Specifically, during the inspection, it was observed that your fnm h as not conducted Annual Product Quality R eviews (APQRs) for the majority of products manufactured at (bH4> manufacturing units. While your fnm provided APQRs for (b)<4 > numerous other OTC drng products manufactured during the review period lack APQRs. Based on batch records reviewed, products missing APQRs include various (bH4> products manufactured at Uni (bH4> Your fnm 's o wn SOP APQR (SOP/Q A/014-06, Section 8.5) -----acknowledges this requiremen t, stating "Annual Product Quality R eview shall be prepar ed for all (b){4) 11 products which ru.·e in the market --------------------------- SEE REVERSE OF THIS PAGE
Observation 5 — Buildings used in the manufacture, processing, packing or holding of diug products
Buildings used in the manufacture, processing, packing or holding of diug products are not maintained in a clean and sanitaiy condition and free of infestation by rodents, birds insects, and other vennin. Specifically, during the inspection conduct ed on [01/15 and 01/16/2026 ], the following de fi cient conditions were observed: a live bird and bird di·oppings were fo und in the ra w material wai·ehouse, approximately 30 feet from ~><4> I packaging materials; appai·ent unidentifi ed black substance was observed covering over 25% of the ceiling surfaces in both the raw material warehouse and finished diu g product storage warehouse; and a gap approximately 1 inch was observed in the dock door of the finish ed product storage warehouse.
Observation 6 — Equipment surfaces that contact components and in-process materials ai·e reactive, additive or
Equipment surfaces that contact components and in-process materials ai·e reactive, additive or absor ptive so as to alter the safety, i de ntity, strength, quality, or purity of the di11g product beyond the official or other established requirements. Specifically, during the inspection conduct ed on [01/15 to l 6/2026], hoses connected to points of use in the Uni1~><4> area and Uni H4> Imanufacturing area were fo und to contain s ta gnant r )(4) mpromising CbH4> !quality and creating microbiological containination risks. The (b)(4) ~ese hoses is used fo r cleaning ~><4> !tanks utilized in the manufacturing of diug products.
Dabur India Limited’s FDA history
Argus HQ has recorded 15 total FDA actions tied to Dabur India Limited: 0 warning letters, 14 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- Does this Form 483 mean Dabur India 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.
- 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 Dabur India Limited had other FDA inspection citations?
- Yes. Argus HQ has recorded 15 total FDA actions tied to Dabur India Limited, including 1 Form 483 inspection citation.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3001413302.
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Related enforcement actions
Full FDA history for Dabur India 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 (2026). Dabur India Limited — FDA Form 483 Inspection, January 16, 2026 (6 Citations). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-dabur-india-limited-2026-01-16-3001413302
"Dabur India Limited — FDA Form 483 Inspection, January 16, 2026 (6 Citations)." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/483/fda-483-dabur-india-limited-2026-01-16-3001413302.
Argus HQ Research. "Dabur India Limited — FDA Form 483 Inspection, January 16, 2026 (6 Citations)." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-dabur-india-limited-2026-01-16-3001413302.
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title = {Dabur India Limited — FDA Form 483 Inspection, January 16, 2026 (6 Citations)},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-dabur-india-limited-2026-01-16-3001413302},
note = {Accessed: July 15, 2026}
}