Key facts
| Firm | Aurolife Pharma LLC |
|---|---|
| FEI / inspection ID | 3014028588 |
| Inspection end date | April 10, 2025 |
| Citation count | 10 |
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 — There is a failure to thoroughly review any unexplained discrepancy whether or
There is a failure to thoroughly review any unexplained discrepancy whether or no t the batch has been already distributed. Specifically, t he following deviations were reviewed and found deficient: a. Investigation Report for Device Malfunction for ,.....__ Cb)C4lSolution USP, CbTC4JComplaint Number A-PC2024-00I opened on 01/11/2024 is deficient. The investigation was initiated after complaint was received due to <6Ht malfunction. During your investigation report, you didn 't identify a root cause associated to manufacturing process. However, your investigation failed to mention that previously, investigations INV-NC-018-015, INV-NCAL-018-001, INV-NCALl 9-004 and DEV-19-013, were initiated for malfunction of the wci during the submission batches manufactured in 2018. It was identified a potential root cause as the Cb><4>011 <6><4; 0 the bottles prior to filling may disrupt the CbT~ nd inability of the1 CbTC41to function, owever, afte r changes to the process were implemented, your 1rm received over a hundred (lo~f complaints forr (b,:r atfunction. Which indicates your investigation was deficient and corrective and.
Observation 2 — 11 (bTC"'f ield Alert Report was not submitted within three working days
11 (bTC"'f ield Alert Report was not submitted within three working days of receipt of information concerning a failure ot one or more distributed batches of a drug to meet the specifications established for it in the application. Specifically, Your firm failed to submit a Field Alert Report (FAR) to the agency within three (3) working days. Your firm failed to follow standard operating procedure (SOP) APL-GP-GEN-0039 Field Alert Reporting Version l.0.0.0, which establishes that an event investigation that indicates potential/confirmed failure of one or more batches of the drug product that is distributed in market is a condition for filing FAR from manufacturing site. Your firm (b11 received a complaint.for the distributed drugE oductl wc1 solution USP! , Lot Numberj (b)<~on Olj l 1/2024 due tor (b11 1malfunction where the patient could not extract drug product from the bottle due toc ; 1 dj01 alfunction however. not FAR was submitted. In addition,.}'our firm received similar complaints for distribute rug.
Observation 3 — Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contaminat io n that would alter the safety, identity, strength, quality or purity of the drug product. Specifically, a. Compounding Room, {6ff1~ CbT1n f theanufacturing area, where compounding un; lit_o oeration for commercial Iproduction ofr - ooro oo~ js performed. houses pieces of equipment - (b)(, [G Cb>< 4 >unt1l December 2024, th isl CbH 4 1 quipment collectively shared the same .le.ownme.0UJ...;ui1unhe"x:::&1&.""Ir0~ s...e..vJdenced..b:\.1 • CbTC4 lDJ(41 ·"concurrently wrtntli'e commercial proauctJon otl CbH 4 prug proauccs were pertormed in the Compounding Room' lOH 4 1fhis was evidenced by logbook entries in Log Book #: I t"ffL Cb1l4 MU It 1p le roanuracnu:m e:..e.a lllnmenTJ3L~~llare.a..aurtn.e ..l llt>Jn.aournctuo w_oro.CU1ci:Jon o_un.e..atlove..oroe1u ci:s-..(b)'{~l in~ udjnQ Cb>(" I Add Continuation Page dJ<'f'GNAru® EMPLOYEE($) NAME ANO TITLE (Print or Type) DATE ISSUED SEE REVERSE Laurimer Kuilan-Torres , Sr. Regulatory Specialist OF THIS 04/ 10/2025 PAGE Yiwei Li, Supervisory Phann aceutical Scientist
Observation 4 — Buildings used in the manufacture, processing, packing or holding of drug products
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition and are free of infestation by insects and other vermin. Specifically, a. Filth, spider web, and insects are found on WCl pallets used to stack and store boxes containing packaging/ 4 4 L------Cb_rl_< )such a _________Cb_H....>n t e warehouse. SOP for Pest and Rodent Control (SOP-HS 1203.00) describes that the Pest and Rodent Control are outsourced to outside contractors. The SOP did not describe how your firm would evaluate the effectiveness of the pest control services to ensure that the manufacturing process, testing, and storage areas are free from infestation of vermin. Upon request, your firm provided (b 114}pest and rodent finding reports generated by the outside contractor. However, there is no documented evi dence that such reports were reviewed by your quality unit and that the effectiveness of the pest control program was evaluated, maintained, and trended on.
Observation 5 — Routine calibration of automatic equipment is not performed according to a written
Routine calibration of automatic equipment is not performed according to a written program designed to assure proper performance. Specifically, The balance with Equipment Id. MF-BS-11 (Serial No. I luTC4l sed for in-process controls in the (bT(4) /." • R CbT(-0. --,..--..-,---,--,- . h. h f F I h anu1acturmg area oo 1s not callbratect wit m t e range o. u. se. or exa[ e, ti e t~w- e1·g - _h_t _b-al_a_n_ce- is_u_s_e for the in-process controls of _,_,...,..--,.--,--..,.,-----,, CbH4lall strengths. The Cb)C4l calibration of balance is conducted usin!! standard we1gnts oetween the range on CbT<~however the in-process (lir(4~ . (6H4J . -1__...,.._, I (b) (4) controls fo _______________1to determine 1we1ght ranges trom 'j (liH~lnaccurate weight ot m process samples can lead to acceptance oC CbT( 4)vith a variance greater •·t-h-an- th_e_e_s-ta"'tblished for the Cbn4l eight and discrepancies in drug content. Add Continuation Page EMPLOYEE($) NAME AND TITLE (Print or Type) DATE ISSUED ~GNATURE SEE REVERSE Laurimer Kuilan-Torres, Sr. Regulatory.
Observation 6 — Testing and release of drug product for distribution do not include appropriate
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release. Specifically, a. During the review of Out of S ecification OOS Investigation OOS-AL2-24-0003, we noted the following • • C: (b}1,4J. (b)l~c;: I • (L I (bff41 f . fi .d fi • in _____ ___,,--,,....., r o ut1on t~ot,...______ e 1c1enc1es: testmg 1or ....,.,,... an out o speer 1cat1on was reported with resul s o CbH4>:?oTAcceptance criteria Cb>< 4>o to c;T; j¾ )- Your investigation could not identify a root cause in the la oratory, and therefore, continue o repea t e test with other bottles as the original sample could not be located. The new tested samples complied with the acceptance criteria and therefore the lot was released for distribution. b. Durin gJhe review of Out of Specification (OOS) Investigation OOS-AL2-23-0007, initiated on 06Jun2023 after 4 Cb><4 \est was out of s ecifications for.
Observation 7 — Laboratory controls do not include the establishment of scientifically sound and appropriate
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity. Specifically, a. Your firm failed to establish a scientifically sound method to test related substances in (bY{41Drug Substance. The method transfer of the Related Substance by HPLC method for H4>was com leted and . (bY{4 (b) (41 effective on 03Au 2023 however testmg for ____..,....._Drug Substance batches (Batch No. No. ___ _,_,__..,.~ (bY{4lised in the submission of -.--.--.----. CbT<4'was__r_e.,....le-a-se_d..,....,...by_ Q_u_a_li...ty Assurance m u y b"22anaSeptem er 2022 for usage in submission batches manufactured on August 2022 and November 2022. Your testing of drug substances was conducted with a method that has not been i~lemented. b. In addition, as documented in Method Transfer of related Substances by HPLC method from (l/ < 4 for ooro . --~oo~ o.r.Qtoc~l- l 98RP-2 l .00, the percentage of difference (%error) between the.
Observation 8 — In-process samples are not representative
In-process samples are not representative. Specifically, c. c. CbT~ . (b)1-4l ------ wCl Bateh manu1actu~ip_J record 1or __"T._ __,.._,......------,--...,..Polut1on U~ p (Batch No. _____ __, requires that,___ 1,.. amples are co ected to r m-process testmg Cb 1 4(Hb-.,.,.th_e_m - anufacturin Cb>14l WC41 • .s am~s are collected f> Y uahty assurances. Cb1l4l . · (b)(4~ -.._,,,,_ _.....,_ ______,........, dated 22SEP2022 requires that amples are co ecte or in-process testing ,__,,,,,,.-__,..... y the _____ _, . d Cb)<4l I __..,.. d Cb>1-4Yb 1· manu acturmg associates an ___samp es are co ecte - .........--.....-• y qua tty assurances. There is no assurance that the sampling approach is a statistically representative o eac product and each lot and has a precise representation of the quality attributes purposed to have.
Observation 9 — Control procedures are not established which validate the performance of those manufacturing
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. Specifically, According to the Operation Instruction of iJ( 41 achine (4.6.2018) WCl in which "the.....,,.......,...., machine must be stored or operated (mandatory)" inc uded room quality re uirements for th l ~oo oom "in which the front art of machine is positioned". The requirements included 4 CbHt owever, a review of our ·•---,--.--.---.--,..--Cb-,H L__gg__Book for -----. ------ (b)(4~ ".':'j ~ Manufactunng Log Books revealed that the above controls mchro1 jj, were not controlled to always meet the __Cb_i)1_~ma..,c·-1.-n_e_r_e_q_u.,..1r_e_m_ents in Room Cb><41---------- Add Continuation Page EMPLOYEE(S) NAME AND TITLE (Print or Type) DATE ISSUED Laurimer Kuilan-Torres, Sr. Regulatory Specialist 04/10/2025 Yiwei Li, Supervisory Phannaceutical Scientist FOOD ANO DRUG ADMINISTRATION DI STRICT OFFICE ADDRESS AND PHONE NUMBER Center for Drug Evaluation and Research OPQ/OPMA 10903 New Hampshire Ave. Silver fJ>Iine...MP 20993 Phone:301-796-2400;.
Observation 10 — Procedures for corrective and preventive action have not been adequately established
Procedures for corrective and preventive action have not been adequately established. Specifically, 1141 Investigation Report for Device Malfunction for ......--. (b polution USP, Cb>1 4 !Complaint Number A-PC2024-00 l o ened on Ol/ 11/2024 is efi ci ent. The inves ti gation was initiated after complaint was received due to <6>1-4lmalfunction. During your investigation report, you didn't identify a root cause associated to manu acturmg process. However, your investigation failed to mention that previously, investigations INV-NC-018-015, fNV-NCAL-018-00 I, INV-NCAL 19-004 and DEV-19-013, were initiated for malfunction of th~ Cb>1 41 duri~g the submission batches manufactured in 2018. It was iden!ified a potent.ial root cause as the Cb><4p~ (ti)(lo the bottles prior to filling may disrupt th lbJC4lhowever, a_fter changes to the process were implemen ed, your firm has received over a hundred (I00) of complaints for Cb)<1malfunction. The corrective and preventive actions implemented were inadequate in that the condition for the ma function of the <6>14 was not corrected before.
Aurolife Pharma LLC’s FDA history
Argus HQ has recorded 1 total FDA action tied to Aurolife Pharma LLC: 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 Aurolife Pharma LLC 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 Aurolife Pharma LLC had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for Aurolife Pharma LLC so far. Argus ingests new FDA records daily.
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Related enforcement actions
Full FDA history for Aurolife Pharma LLCCompiled 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). April 10, 2025 FDA Form 483 for Aurolife Pharma LLC — 10 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-aurolife-pharma-llc-2025-04-10-3014028588
"April 10, 2025 FDA Form 483 for Aurolife Pharma LLC — 10 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-aurolife-pharma-llc-2025-04-10-3014028588.
Argus HQ Research. "April 10, 2025 FDA Form 483 for Aurolife Pharma LLC — 10 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-aurolife-pharma-llc-2025-04-10-3014028588.
@misc{argushq_argushq_ai_483_fda_483_aurolife_pharma_llc_2025_04_10_3014028588_2025,
title = {April 10, 2025 FDA Form 483 for Aurolife Pharma LLC — 10 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-aurolife-pharma-llc-2025-04-10-3014028588},
note = {Accessed: July 15, 2026}
}