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 Ipca Laboratories 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 Ipca Laboratories Limited had other FDA inspection citations?

This is the only FDA action Argus HQ has on file for Ipca Laboratories Limited so far. Argus ingests new FDA records daily.

FDA Form 483 — Ipca Laboratories Limited (December 5, 2025)

Key facts

Firm	Ipca Laboratories Limited
FEI / inspection ID	3006057101
Inspection end date	December 5, 2025
Citation count	3

In short: FDA inspected Ipca Laboratories Limited in India and issued a Form 483 listing 3 inspectional observations following an inspection that concluded 2025-12-05. FDA records classify Ipca Laboratories Limited as a api (animal origin) 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.

Citations explained

Observation 1 — Buildings and facilities used to manufacture APis are not maintained appropriately to

Buildings and facilities used to manufacture APis are not maintained appropriately to facilitate cleaning and to minimize potential contamination. Specifically, the clean rooms in manufacturing block~ that are used to manufacture ~bJ<4> JUSP and ~ )(4) JUSP fo r the US market, are not maintained appropriately to facil itate cleaning and to minimize potential contamination. For example: A . On 12/ 1/2025, during the inspection of product [!bl <4> Area in manufacturing Blocl<~ a big chunk (approximately 5 inches long and 2.5 inches wide) of missing and peeling off paint was observed on the ceiling where i!i>H4> ( equipment ID: 10i<bH4J JOI) is housed. This is an open processing area where the APis are exposed to the room environment. You failed to adequately maintain this area to ensure chipping and peeling off paint is not inadvertently impacting the quality of the AP ls manufactured in this room. B. On 12/ 1/2025, during the inspection of Weighing & Packing Area in.

Observation 2 — The suitability of analytical test methods is deficient for its intended use

The suitability of analytical test methods is deficient for its intended use. SPecwcallv!tjanalytical method verifi cation studies performed to test assay and organic impurities in (b)(4 ) 1 SP , are deficient. {b)(4))7 fb)(4) IOn 12/2/2025, you tested US batches of '!bll-4J SP using two HPLCs. The equipment QC-INST-07 was used for Assay by HPLC test, and equipment QC-INS T-06 was used for Organic Impurities by HPLC test. For these analyses, the acceptab le ll>H4l 1l>ll4l . . HPLC column temperature was set a1::.:( C to C. Your QC Head confirmed on 12/2/2025 that slight change in column temperature can cause change in the el usion time of the peak of interest and can potential ly impact the analysis. The site failed to provide any scientific data generated through a controlled {b) {b)(4) study to demonstrate that the HPLC column temperate range of<4J C to 'C can generate reproduceable and accurate results. 6MPLOYGE(S) SIGNA Tf.JAE ENPt.0Yee(3) ~MO TITI.Z (McOf Typ.).

Observation 3 — There is a lack of adequate controls in place to minimize the

There is a lack of adequate controls in place to minimize the carryover of the residual materials into successive batches of the sa me intermediate or API. Specifically, you failed to establish the maximum number of days for wh ich the APls can be manufactured in a campaign. For example: Your control procedure TARA/PRD/088/RO I, Procedure, Criteria, and Validity for Cleaning of Manufacturing P rocess Equipment requires Type-B cleaning (more rigorous cleaning) of the process equipment be performed between the different products or afte lb><4 > batch of the same product. Th is procedure does not define the campaign length in terms of maximum number of days. For example, , • {b)(4) ~lb)(4) Itwo manufacturing campaigns for USP and (b)(4) 'tJ '(b)(-4) (b)(4) . . . SP I ,lasted for respecti ve l y. You faded to provide scientific data derived through a controlled study to demonstrate that the residual material from the previous batch is not carried over into.

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.

Ipca Laboratories Limited’s FDA history

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

Frequently asked questions

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 Ipca Laboratories 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 Ipca Laboratories Limited had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for Ipca Laboratories Limited so far. Argus ingests new FDA records daily.

See if this 483 escalates to a warning letter — before your auditor asks.

Free weekly briefing tracks every FDA inspection outcome.

Full FDA history for Ipca Laboratories 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). FDA Form 483 — Ipca Laboratories Limited (December 5, 2025) — 3 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-ipca-laboratories-limited-2025-12-05-3006057101

MLA

"FDA Form 483 — Ipca Laboratories Limited (December 5, 2025) — 3 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-ipca-laboratories-limited-2025-12-05-3006057101.

Chicago

Argus HQ Research. "FDA Form 483 — Ipca Laboratories Limited (December 5, 2025) — 3 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-ipca-laboratories-limited-2025-12-05-3006057101.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_ipca_laboratories_limited_2025_12_05_3006057101_2025,
  title = {FDA Form 483 — Ipca Laboratories Limited (December 5, 2025) — 3 Citations},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-ipca-laboratories-limited-2025-12-05-3006057101},
  note = {Accessed: July 15, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗