Key facts
| Firm | Piramal, Piramal Pharma Limited |
|---|---|
| FEI / inspection ID | 3008763768 |
| Inspection end date | February 17, 2025 |
| Citation count | 3 |
Citations explained
Observation 1 — Written records of investigation of an active pharmaceutical ingredient (API) do not
Written records of investigation of an active pharmaceutical ingredient (API) do not include follow-up. Specifically, {6)(4} A. Four (4) deviations er.e-{.;~ll,orted between March 06 - March 18, 2024, fo TL_ Cb><4> 4 09, due to th ~ i,., teps ofb (b,c batches being stuck_~ ----1 (6Jlill ,-.. CbH4t cycle. T he first mc1 ent occurred on arc ioo,2 0'24, fo itlatc~o· _,,..,.....,,-,---,..,.....1Lhe second 4 incident occurred on March 09, 2024, for (b)(1Batch No. Cb>< the third incident occurred 4 4 on March 12th 2025 for <6R >Bl'l.tcb..N.Cbn>"" ~ c and the fourth incident o..s:;curred on March(b)(ilJ ,~, . (6f(4l 17, 2024 for...____,_Batch No. _____.wrucn was her reprocessed mto _____ The following deficiencies were noted concerning the deviations: 1. There is no documented quality risk assessment performed to determine continued_ . (b) (ill (b1 (4) manufactunng operat10ns of subsequent .................-- batches on the same (b,{,l~hD9, while the inyestigation remained open fo r the deviation involving batch, Cb><~ t N >J<<llf-'a C.
Observation 2 — The cleaning of equipment is inadequate
The cleaning of equipment is inadequate. Specifically, A. Cleaning procedures have not been validated for shared equipment used to manufacture and process crude APis for the U.S and other global markets. For example, the following shared equipment have not been evaluated as part of a clean in g validation program: CbTOO CbTt<ll W(1 · · 1. _J) 4 was used for __,.J step mvolvmg Cb><4> j ctivity Da te : December 3 1, 2024, to January 02, 2025, ana "--,------,....,,...... December 28, 2024, to December 31 2024. The same batc h..F~~> • 1 d .:. (bJ(4) • l . (b)<<llB h N " preVIous y use 1or _____,step mvo ymg ~-:---,:-::-:,-,------ ate o. ._______ Activi Date· December_25.,.202.!lll>tfl>De r mbeJ;>, 6, 2024. ---. ~ 2. Cb><4> 04 was used for (b) step involving Cb>< ~ tivity Date: November 28, 2024. to December O1, 2024, 00~ ~ ~ ~~ . and_ __, w. J om November 27 - 28 ~2024. The samr.
Observation 3 — Master production and control records lack complete manufacturing and control instructions, written
Master production and control records lack complete manufacturing and control instructions, written specifications, and precautions to be _followed. Specifically, (bT(4l A. Section 8 .1 8 of the Master Batch Manufacturing Record (BMR) of Crude (b)(4) reciuires the onerator to1 (bH4l·i,------~ r (b><4>-~.... !Ho wever, MBR ~~cp~ Ul,;l UU~cCu ous 10 11 ,_ __,, _________ _ps per t he M ts R instructions. In addition, the( (b)(4:st ep has greyed start and end time sections and checked by sections. Tlieretore, operators are not able to appropriately document the cycle start and end time. For example: • • J (6)(4) '1{il I. The executed BMR for Crude "~------ Batch No (b in cl uded• (b)(4-r , (b)(4), documentation o ...,_,,---,---,--'' cycles mstead of the ---_.,......., nstructed by the master BMR. No written deviation has been initiate 'lorthe change in the validated procedure. j (b)14l · CbT(4l 2. The executed BMR for Crud~ !Batch No .I (b)( ' 'ncluded the 4 following written.
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.
Piramal, Piramal Pharma Limited’s FDA history
Argus HQ has recorded 1 total FDA action tied to Piramal, Piramal Pharma Limited: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- Has Piramal, Piramal Pharma Limited had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for Piramal, Piramal Pharma Limited so far. Argus ingests new FDA records daily.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3008763768.
- 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.
See if this 483 escalates to a warning letter — before your auditor asks.
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Related enforcement actions
Full FDA history for Piramal, Piramal Pharma 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 (2025). FDA Form 483 — Piramal, Piramal Pharma Limited (February 17, 2025) — 3 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-piramal-piramal-pharma-limited-2025-02-17-3008763768
"FDA Form 483 — Piramal, Piramal Pharma Limited (February 17, 2025) — 3 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-piramal-piramal-pharma-limited-2025-02-17-3008763768.
Argus HQ Research. "FDA Form 483 — Piramal, Piramal Pharma Limited (February 17, 2025) — 3 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-piramal-piramal-pharma-limited-2025-02-17-3008763768.
@misc{argushq_argushq_ai_483_fda_483_piramal_piramal_pharma_limited_2025_02_17_3008763768_2025,
title = {FDA Form 483 — Piramal, Piramal Pharma Limited (February 17, 2025) — 3 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-piramal-piramal-pharma-limited-2025-02-17-3008763768},
note = {Accessed: July 15, 2026}
}