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 Hikal 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.

February 7, 2025 FDA Form 483 for Hikal Limited

Key facts

Firm	Hikal Limited
FEI / inspection ID	3003560263
Inspection end date	February 7, 2025
Citation count	3

In short: FDA inspected Hikal Limited in India and issued a Form 483 listing 3 inspectional observations following an inspection that concluded 2025-02-07. FDA records classify Hikal Limited as a api and intermediate 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 — Written procedures are deficient specifically A

Written procedures are deficient specifically A. Your firm's vendor qualification procedure, CQA01002-0l, indicates that vendors are assessed on the number of consecutive rejections encountered during incoming material inspection. However, no provision for vendors that provide materials that are identified as deficient later in the manuff dl!ig 4 orows m...aft.er. distributi]1- Gfli(xample, your fi l ce~J.tin,J..e c{~plaints regarding Cb>< [ Cb><4!drums an hds, supplied by (6) jA n on-site audit of the vendor was performed by your firm' s personnel in April 2024, to which the vendor responded with a bevy of procedural changes, facility improvements an~ g,lfowem. co¼plaints related to 4 drum fibers and pieces of the lids, continued to occur. Cb>< aintain a "A" rating with a" zero-rejection rate", despite the continuous nature ofreceived complaints. r l~::i;ate 4 vendors have been qualified, however, according to your finn's management team, [ CbTC4},rovide approximately greater than I ~ Vo, however, an exact percentage could not be venfied.

Observation 2 — Back-up data is not appropriately protected from unauthorized access, manipulation or deletion

Back-up data is not appropriately protected from unauthorized access, manipulation or deletion. Specifically, During a walkthrough of your firm's microbiology laboratory, a "qc" folder located on the server (IP: 172.21.21.25) contained a folder titled "CHROMELEON 6.8 BACKUP BEFORE MIGRAGTION". The folder ~nd contained filed had no fiteyrotection~/r cess..,cont.J:cls...a fu.: : Mn; d "GC-213", was fully accessible and able to be deleted ·while logged m Semor Manager, Microbiology. although the deletion process was aborted to preserve data. =nor to observation during the microbiology laboratory wal.kthrough, your firm's IT personnel were seemingly unaware that the Chromeleon backup data was saved to User file folders and not the designated IT Folder/Backup System. The backup folder contained ~uipment specific folders with data from Gas Chromatograph .LQCl.ruJ.dj..iauid..CJ,(,Q.U,VlfQgran}:L(J ..c1,j {tiff~ .~ ~ (b)(4 OA.TE IS$1.EO Marcellinus D Dordunoo, Investigator 02 / 0 7/ 202 5 SEE REVERSE /2_LLJ-- OF THIS PAGE FORM Fl>A 4 83 (09/08) ,..,._,,ovsr-0tr oo~ooso• "" INS PECTfONAL OBSER VATlON Page 5 of.

Observation 3 — Incidents related to computerized systems that could affect the quality of intermediates

Incidents related to computerized systems that could affect the quality of intermediates or AP Is are not recorded and investigated. Specifically, ' ,, (6Hll'o • • I (6}"{4l"J:) k" ) • 11 d b p Your fimu s rocessmg eqmpment ac mg 1s contro e y a rocess Logic Controller (PLC) in conjunction with a Human Machine Interface (HMI-16). ev, ~ents that are encountered generate a temporary notification visually on the HMI, and perl CbTC 4 equire Production personnel to contact the engineering department. However, neither the computerized system/software used to manage the process, nor the written procedure/production batch record require any documentation of the events encountered. Upon request, your firm could not provide a single documeQted instance of any of the 37 events, requiring engineering department notification, der 1e.d4f n (bJ ince installation of the system. There is no mechanism to assess the adequacy of the CbH ..- 1... • rocessmg. *DATES OF INSPECTION 02/03/2025 (Mon), 02/04/2025 (Tue), 02/05/2025.

Hikal Limited’s FDA history

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

Frequently asked questions

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 Hikal 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.

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Full FDA history for Hikal Limited

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 (2025). February 7, 2025 FDA Form 483 for Hikal Limited — 3 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-hikal-limited-2025-02-07-3003560263

MLA

"February 7, 2025 FDA Form 483 for Hikal Limited — 3 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-hikal-limited-2025-02-07-3003560263.

Chicago

Argus HQ Research. "February 7, 2025 FDA Form 483 for Hikal Limited — 3 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-hikal-limited-2025-02-07-3003560263.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_hikal_limited_2025_02_07_3003560263_2025,
  title = {February 7, 2025 FDA Form 483 for Hikal Limited — 3 Citations},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-hikal-limited-2025-02-07-3003560263},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗