Key facts
| Firm | Orchid Pharma Limited |
|---|---|
| FEI / inspection ID | 3003747558 |
| Inspection end date | February 18, 2025 |
| Citation count | 6 |
Citations explained
Observation 1 — You have not establish ed the written procedure to ensure that your
You have not establish ed the written procedure to ensure that your process can per fo1m e ffectively and reproducibly to manufact ure an inte1mediate or API meeting its predete1mined specifications and quality attributes. Specifically, A. You have attempted to concunently validate the manufacturing of j CbTC1 4 (bH"j as per your Repo1i N o. CPV~ (bH ~/0 01 Effective date 6/28/2019. You _ (b)(4) hi 1·d . b h . (b)<4l j t ·ee process va 1 ahon ate es m ·1 I ach batch (b)(4) . (b)(4 . (b)(4).........-- was loaded eauallv across 1!11 the ( (m._____ m each l You sampled the material fo r ! (b)~al~s1s"'[fo r in process control) as descn 6ed m your procedure, In- 4 process Sampling from! (b) ~ SOP No. PRD.14.0 6. 08 Version N o. 008 Effective date • 1 fi r:T(4J 1 I •CbT(4J I d 6 1/2024_. The sample mate na s ·om eacp were co lect ed.
Observation 2 — Appropriate qualification of critical equipment and ancillaiy systems are n ot completed
Appropriate qualification of critical equipment and ancillaiy systems are n ot completed according to established specifications. Specifically, (bH4 • (bH4 , i--(bH4~ 1n ID's R. (bH<l)-::Th ::-----,.----,1"'"'·fi,__,_,.....- f h (b)(4) . hi d hi i1 <"ff~i e operation qua 1 1cahon o t ese 1s ac eve t . ·oug~L...J (bH4l-s..,..tu_d.,_...1-es-- as documented in Repo1i No. (b)l4l Effective ""'d-at_e_9..,/2_5___/... 2024. The (bT is can -ied out according to the Proced ure for (bH SEE REVERSE OF THIS PAGE EMPLOYEE/SJ SJGNA TURE EMPtOYEE/ S) NAME AND TITLE (Prinlor Type} . . Digit ally signed by RaJIV R. Ra ji v R. Srivast ava -5 Raj iv R Srivastava, cso Srivastava -5 Date: 2025.02.18 16:21:56 +05'30' DATE ISSUED 02/18/2025
Observation 3 — You failed to test samples of each component fo r confo1mi ty
You failed to test samples of each component fo r confo1mi ty with all appropriate written specifications for purity, s ti-ength, and quality. You also failed to establish the reliability of component supplier analysis on which you rely in lieu of ce1tain tests through appropriate validation of the supplier's test result at appropriate inte rvals. Specifically, A. You use (bTC4l _USP in the manufacturing of (b)l4l (bTCl t\PI fo r the US market. The specification fo r endotoxin in the comin raw material is NMTg iJ EU/mg, that is higher than the release specification fo r (b) API, 4 NMT (bH ~U/m g. In addition, you do not test this raw material fo r bi ob urden prior to release fo r manu actunng. (bY{4 B. You use (bTCl in the manufacturin of (b)l4l APit or tlie US market. You do not test ,,_,___ -.----,.----,-...bioburden. You decided to remove the testing requirement for endotoxin from the specification SEE REVERSE OF.
Observation 4 — Cleaning procedures do not contain sufficient details to enable operators to clean
Cleaning procedures do not contain sufficient details to enable operators to clean each type of equipment in a reproducible and e ffective manner. Specifically, You do not have cleaning procedures for your manufacturing equipment. You use product specific batch records fo r equipment cleaning. These batch records include all the major manufacturing equipment and a sUilllllaiy of the unit operations fo r cleaning. The s umma1y lacks details to en ab le operators render an e ffective and reproducible cleaning. E. g. Cb)l4l • 1. 1A. You manufacture I Cb)l4 API for the US market in I ·i m mu tip e non- dedicated e~uipmen t. Cleaning of SQme of the eguipment is sUilllll arized in Batch Record fo r Cleaning of CbH 4jat l CbH4 Effective date 7/25/2023. The batch record SEE REVERSE OF THIS PAGE EMPLO YEE/SJ S JGNA TURE EMPtOYEE/S) NAME AND TITLE (Prinl or Type} Di g ita lly signe d by Rajiv R. Rajiv R..
Observation 5 — Appropriate conti·o ls are not exercised over computer or related system to
Appropriate conti·o ls are not exercised over computer or related system to assme that the changes in the master production or conti-ol records or other records are instituted only by authorized persons. Specifically SEE REVERSE OF THIS PAGE EMPLO YEE/SJ SJG NA TURE EMPtOYEE/S) NAME AND TITLE (Prinl or Type} . . Digitally signed by Ra JIV R. Raj iv R. Sr ivastava-$ Raj iv R Sr ivas tava , cso Srivastava -S Date:2025.02.18 16:24:13 +05'30' DATE ISSUED 02/18/202 5
Observation 6 — The responsibilities and procedure applicable to the quality control unit are n
The responsibilities and procedure applicable to the quality control unit are n ot in writing and/or fully fo llowed. Speci fi cally, your procedure for Training and Development SOP No. HRD.0 1. 01 Version No. 015 Effective date 11 /20/2023 has a provision for periodic CGMP training a \ (b 111 However, review of 4 your training records confum ed that there were ~t least (b1141 associates (out of total CbH employees) whose GMP training was past due fo rj Cb>< 4j SEE REVERSE OF THIS PAGE EMPLOYEE/SJ SJGNA TURE EMPtOYEE/S) NAME AND TITLE (Prinlor Type} . . Digitally signed by RaJ IV R. Rajiv R. Srivastava -s Raj iv R Srivastava, cso Srivastava -5 Date: 2025.02.18 16:24:46 +05'30' DATE ISSUED 02/18/2025
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.
Orchid Pharma Limited’s FDA history
Argus HQ has recorded 1 total FDA action tied to Orchid Pharma 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 Orchid Pharma 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.
See if this 483 escalates to a warning letter — before your auditor asks.
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Related enforcement actions
Full FDA history for Orchid 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 Inspects Orchid Pharma Limited: Form 483 with 6 Citations (February 18, 2025). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-orchid-pharma-limited-2025-02-18-3003747558
"FDA Inspects Orchid Pharma Limited: Form 483 with 6 Citations (February 18, 2025)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-orchid-pharma-limited-2025-02-18-3003747558.
Argus HQ Research. "FDA Inspects Orchid Pharma Limited: Form 483 with 6 Citations (February 18, 2025)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-orchid-pharma-limited-2025-02-18-3003747558.
@misc{argushq_argushq_ai_483_fda_483_orchid_pharma_limited_2025_02_18_3003747558_2025,
title = {FDA Inspects Orchid Pharma Limited: Form 483 with 6 Citations (February 18, 2025)},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-orchid-pharma-limited-2025-02-18-3003747558},
note = {Accessed: July 13, 2026}
}