Key facts
| Firm | Natco Pharma Limited |
|---|---|
| FEI / inspection ID | 3004540906 |
| Inspection end date | June 19, 2025 |
| Citation count | 7 |
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 — Aseptic processing areas are de fi cient regarding the system for monitoring
Aseptic processing areas are de fi cient regarding the system for monitoring environmental conditions. CbT(, Your fnm operatesI CbT, non-viable 2article monitoring egui2mentl CbH 4j used to perfonn and Igenerate test data for non-viable (NVP) count used in environmental monitoring and cleanroom qualification activities in Grade A, Grade B, Grade C, and Grade D areas in suppo1t of aseptic manufacturing oe_e1~ationsjn your U!}it~c 4lAseptic processing area, used for manufacturing of 4 m ml an m ml for the US Market. Durmg our review, we observed that your quality lllllt does not review t e electronic data generated, stored and archived, only using printout as primaiy data. During our review of the electronic data, environmental monitoring for non-viable paiticles (NVP) during aseptic operations was found to be inadequate. For Example, I <:J />< J c\~<j r:J (l • • A. For e leven (11) fina l samp le report results for CbT<41 μm and CbTCl μm pa1ticles retrieved from the softwai·e.
Observation 2 — Equipment and utensils are not maintained at appro priate intervals to prevent
Equipment and utensils are not maintained at appro priate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the dmg product. On 10 J une 2025, we observed the fo llowing discrepancies in y~o~u· Unirn aseptic processing area, which includes a Grade B suppoiting room and a Grade A 1 Cb><1 restricted access baiTier system ~ RABS): -Damage on the wall above and below the clean room phone panel in the Gra de A exten de d laminai· airflow (LAF) ar ea at the stait of th~ RABS, creating rough s urfaces. (tif(4l -Expose~ bolt threads in the G ra de A ~ Tc1LAF (referred to as a1 Ctif< 4lus ed tol [ Cb1 , vials from the fillin~ RABS to the! Cb><4)RAB S. -Gaps and rough edges on both comers of the extended LAF frame by the sealing machine, which was in both G ra de A space and G ra de B.
Observation 3 — Procedures designed to prevent microbiological con tamination of mug products pmpo1ting to
Procedures designed to prevent microbiological con tamination of mug products pmpo1ting to be sterile did not inclu de adequate validation of the aseptic process. A. We observed the following discrepancies while reviewi1 the videos of the dynamic condition smoke study (airfl ow visualization) perfo 1med in your Unit ~ aseptic processing area in December 2024: -Only limited po1tions of th~ RABS were visible at a time due to the zoom ed in camera angle, which prevented adequate assessment of the wholistic airfl ow patterns in the Grade ~ RABS. -The smoke generation device was not visible in the majority of the videos, which prevented dete1mination of which way the smoke was being blown by the generation device. (liT<4l (1irc"'j (1irc"'j r~ (lir(4j ,~; The video of th~ ILAF 1 used to 1 vials from the fillin~ RABS to the I ~S did not include adequate smoke to dete1mine the airflow patterns. 1 SEE REVERSE OF THIS PAGE EMPLOYE E($) SIGNATURE.
Observation 4 — There is a failure to thoroughly review any unexplained discrepancy and the
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been a h-eady distribute d. A. Your fnm did not per fo1m a disinfecta nt efficacy study when a new microorganism was identified during an OOS investigation for environmental monitoring. r Tc 41air sampling per fo1med on 21 March 2024 in the Unit I t"ff1 (Grade D) near the change room door resu lted~ CFU/cubic SEE REVERSE OF THIS PAGE EMPLOYE E($) SIGNATURE Arsen Karapetyan, Investigator - Dedicated Drug Cadre ~~~ °"" Wayne D Mcgrath, Investigator =~~~· X """" DATE lSSUEO 6/ 1 9/2025
Observation 5 — Procedures designed to prevent microbiological contamination of diug products pmpo1iing to be
Procedures designed to prevent microbiological contamination of diug products pmpo1iing to be sterile are not established, written and fo llowed. As of 13 June 2025, your fnm does not have any employees fu lly quali fied to perfo1m 100% visual SEE REVERSE OF THIS PAGE EMPLOYEE($) SIGNATURE Arsen Ka ra pe tya n, I nves ti ga t o r - Dedica ted Drug Cad re ~~~ °"" Wayne D Mcg rat h, I nves ti ga t o r =~~~· X """" DATE lSSUEO 6/ 1 9/2025
Observation 6 — Buildings used in the manufacture, processing, packing, or holding of a chug
Buildings used in the manufacture, processing, packing, or holding of a chug product do not have the suitable constm ction to facilitate cleaning, maintenance, and proper operations. Your Uni~ aseptic process ing ar ea is not adequately visible from th( (bY{4J vi ewing windows. During aseptic filling operations, your employees work in a Grade B suppo1i ing room containing Grade A ~Sand Grade A extended LAFs. We attempted to observe the filling operations from the (bY{4j technical ar ea viewing window and the packaging room viewing window, but we were unable to observe the filling, stoppering, and sealing equipment, including all interventions relat ed to these critical areas. We were unable to enter the Grade B suppo1i ing room during filling operations due to gowning qualification requirements and media fill vali da tion da ta fo r maximum number of people in the room during filling. This aseptic processing area is the on ly aseptic filling line at your fnm.
Observation 7 — EMPLOYE E($) SIG NATURE DATE lSSUEO Ar sen Karap etya n
EMPLOYE E($) SIG NATURE DATE lSSUEO Ar sen Karap etya n , I n ve s ti g at o r - Dedi c ated 6/ 1 9/202 5 SEE REVERSE °"" ~~~ Dr ug Cadre OF THIS PAGE Wayn e D Mcg rat h , I n ve s ti g at o r =~~~ · X """ "
Natco Pharma Limited’s FDA history
Argus HQ has recorded 1 total FDA action tied to Natco Pharma Limited: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3004540906.
- 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.
- 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.
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Related enforcement actions
Full FDA history for Natco 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). Form 483 Record: Natco Pharma Limited, June 19, 2025 — 7 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-natco-pharma-limited-2025-06-19-3004540906
"Form 483 Record: Natco Pharma Limited, June 19, 2025 — 7 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-natco-pharma-limited-2025-06-19-3004540906.
Argus HQ Research. "Form 483 Record: Natco Pharma Limited, June 19, 2025 — 7 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-natco-pharma-limited-2025-06-19-3004540906.
@misc{argushq_argushq_ai_483_fda_483_natco_pharma_limited_2025_06_19_3004540906_2025,
title = {Form 483 Record: Natco Pharma Limited, June 19, 2025 — 7 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-natco-pharma-limited-2025-06-19-3004540906},
note = {Accessed: July 13, 2026}
}