Key facts
| Firm | Exela Pharma Sciences LLC |
|---|---|
| FEI / inspection ID | 3008563008 |
| Inspection end date | November 15, 2024 |
| Citation count | 15 |
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 — Written records of investigations into unexplained discrepancies do not always include the
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. Specifically, 503B Outsourcing facility A. L,,_____________ (b) (4) ____. edia lot ~ (b) (4) sed for release sterility testing of Sodium Acetate failed initial growth promotion testing. Your firm invalidated two tests of this lot of mectia and assed the third test without scientific •ustification. The initial test was performed on _____ (b) (4)__. etested on _____ (b) (4) and retested •••••••1 (b) (4) with passing results on _ (b) (4) Your firm's investigation, QE-000487, states that human performance was determined to be the root cause of the failed testing events. Your firm stated that there was no product impact based on this investigation. Your firm did not document any specific human error identified w~ edj_a...Eq,-1 Lot (b) (4) was used in sterility testing of Sodium Acetate lo- (b) (4) ._(b) (4) __~_ ... aand (b) (4) our firm released these lots of Sodium Acetate.
Observation 2 — The responsibilities and procedures applicable to the quality control unit are not
The responsibilities and procedures applicable to the quality control unit are not fully followed. Specifically, Drug Manufacturer Your firm filled Sodium Bicarbonate Injection, USP lot - (b) (4) ANDA 211091, in Augusta facility grade A, B, C, and D areas that were tagged as "QA HOLD". This lot was filled in Augusta facility on 11/6/2024. Quality hold was placed on the entrance to the 'i (b) (4) I' line on - (b) (4) The quality hold was placed on the room while waiting for l•--• (b) (4) EPA certification to be completed and reviewed.
Observation 3 — Procedures designed to prevent microbiological contamination of drug products purporting to be
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed. Specifically, Drug Manufacturer A. Y ou~ ly perform Disinfectant Efficacy Studies for (b) (4) and - (b) (4) on Sterile Nitrite Gloves, RPT-002136, Version: 1.0 Effective Date: 24 March 2022. No contact time was documented for the sterile nitrile glove study performed and a dilution error was carried over the repeated study •fied as not impacting the study due to a -(b) (4)og reduction (Log . (b) (4) ather than Log I(b) (4) .(b) (4) og reduction was attributed to a lower bacterial concentration. Drug Manufacturer B. Your firm has not demonstrated that isinfectant is adequately used. For example, Surface Disinfectant Efficacy Studies contracted to challenge disinfectant efficacy testing of (b) (4) against Candida albicans did not meet the (b) (4) criteria for test surfaces: (b) (4) (b) (4) n (b) (4) . The disinfectant criteria passed criteria for all other.
Observation 4 — Laboratory records do not include the initials or signature of a second
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy and completeness. Specifically, 503B Outsourcing Facilitv and Drug Manufacturer Your firm contemP,oraneous two-person check during reading and data entry of environmental -(b) (4) lates in the..._ (b) (4) __...,system. A single operator reads environmental plate counts takes pictures of positive counts (no pictures are taken of negative counts), enters results in the .,_ (b) (4) ___.system and later results are reviewed and verified by QC personnel. There is no assurance that the operator has entered data accurately (missed or misread plates counts) at time ofreading. In addition, miscounted plates were observed in the microbiology lab on 11/6/2024. Miscounted colony forming units are as follows: faile Plate number Sample location Sample date Sample type Number of Colony Forming Units cfu on late Analyst count (b) (4) (b) (4) EMPLOYEE($) SIGNATURE EMPLOYEE($) NAME AND TITLE (Print or Type) DATE.
Observation 5 — --- Appropriate controls are not exercised over computers or related systems to
--- Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Specifically, Drug Manufacturer /(b) (4) A. Your firm failed to generate accurate and complete records in a legible, original or a true co y of electronic records suitable for inspection and review. During the implementation o_ ._(b) (4) ___. System, version ___ (b) (4) leted on (b) (4) under the follo~nJZ...Cfange controls: a. Change Co and (b) (4) to---- (QE-000194- L_J for Phase ■ b. CR-12459 (b) (4) c. QE-000584 (b) (4) (b) (4) The affected data transmon trom ____ (b) (4) ystem, during Phase and completed on -(b) (4) (b) (4) it was noted that the format used to present laboratory investigations, deviations, change controls, and other critical quality documentation is not conducive to effective review. The information presented is displayed in metadata format in a tabular layout, which.
Observation 6 — The calibration of instruments and recording devices is not done at suitable
The calibration of instruments and recording devices is not done at suitable intervals in accordance with an established written program. Specially, Drug Manufacturer (b) (4) A. Calibration certificates for the Analytical balances (Asset ID# QC2209 and Asset ID# QC2493) and Top loading balance (Asset ID#(b) (4) located in the QC Chemistry Laboratory, were found to be deficient. The reproducibility testmfue calibration certificates for these balances do not meet the required specifications to ensure suitability of the balances before use. These analytical and top loading balances are used for weighing reference standards and solution preparation for testing of raw materials, in-process, and finished products. B. Analytical balance, (Asset ID# QC2209), located in the QC Chemistry Laboratory was observed to have poor maintenance (i.e. appeared to have rust/corrosion, displayed defective side doors that did not open as expected). This analytical balance is used for weighing reference standards and samples used for evaluation and release of manufactured products that use data generated by.
Observation 7 — Laboratory records do not include complete records of any testing and standardization
Laboratory records do not include complete records of any testing and standardization of laboratory standard solutions. Specifically, Drug Manufacturer Your firm failed to have analytical data to support the stability of Resolution Solution used during the sample anal sis of a sterile product identified as: Tranexamic Acid Injection, 10mg/mL, 100 mL IV Bag (i.e. Lot# ____ (b) (4) Released on: 13 AUG 2024. According to laboratory record (Book: .______ (b) (4) _. (b) (4)the resolution stock solution was prepared in .._ _. nd it has been used for the evaluation and further release of manufactured batches of this Tranexamic Acid Injection. This resolution solution is a combination ofTranexamic Acid Related (b) (4) and Tranexamic Acid for which the Tranexamic Acid standard solution has been identified as stable for -(b) (4) Document: QCMET-000179). Your firm indicated that as per SOP-QC-000075: "Procurement, Receipt, Storage, and Expiration Dating of Laboratory Chemicals", Document Version 2.0, Effective Date: 09 Feb 2021. As per Table 1.
Observation 8 — Established laboratory control mechanisms are not followed and documented at the time
Established laboratory control mechanisms are not followed and documented at the time of performance. Specifically, Drug Manulacturer 1[(b) (4) A. Retain samples for commercial products and raw materials were not stored in their designated locations as required by SOP-000024: "Quality Assurance Retain Manag_e-ment", Document Version: 8.0, Effective Date: 16 Mav 2024. Samples identified i (b) (4) inventory log as being located on the-(b) (4) and l(b) (4)!shelves were not found. Your Retain 7 Manager was unable to locate it. Additionally, the room was cluttered, with retain samples and raw materials stored in a packed manner, which may have contributed to the difficulty in locating the samples and increased the risk of misplacement or improper storage. For example: Product Name Exela Lot Number Qty Storage Location lPentamidine Isethionate for Injection ( l 50mg/mL, 2mL fill)300mg/vial, l0mL Vial (Finish Drug Product) Streptomycin for Injection, USP, 200mg/mL, lg/vial, l0mL vial (Finish Drug) 20mL Vial, Clear, Type I Glass Tube (Raw Material) (b) (4)
Observation 9 — There is no written testing program designed to assess the stability characteristics
There is no written testing program designed to assess the stability characteristics of drug products. Specifically, 503B Outsourcing Facility Your firm does not have stability data to support a 6-month expiration date for Sodium Chloride rn·ection 0.9% Injection, USP packar d in 500mL polx ro lene IV bags. Your firm produced-(b) (4) (b) (4) (b) (4) (b) (4) batches of Sodium Chloride in _ }v bags in and placed them on stability for potential
Observation 10 — Employees engaged in the manufacture and processing of a drug product lack
Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions. Specifically, 503B Outsourcin Facili (b) (4) A. qualification(b) (4) Your firm's visual inspection ■ s inadequate. i. Your firm' s visual inspection kit used during qualificati U not representative of the (b) (4) visual inspection process. Your fir:p::u;_yisuaUnsoection - s comprised of■(b) (4) ials of a variety of vials sizes ranging fron - =- (b) (4) --=--.....,...-.... These vials also contain a variety of products depending on the vial size. During visual inspection of a production batch the visual inspection process is performed on (b) (4) and (b) (4) 11.(b) (4) Your firm's qualification - oes not contain all defects found in production lots. For example, your firm's defect classifications are missing from the following vial qualification., (b) (4) he clear vial inspectio nll (b) (4) does not include critical defects; gross high fill and gross low fill. The clear.
Observation 11 — EMPLOYEE(S) SIGNATURE EMPLOYEE(S) NAME AND TITLE (Print or Type) DATE ISSUED 11/1
EMPLOYEE(S) SIGNATURE EMPLOYEE(S) NAME AND TITLE (Print or Type) DATE ISSUED 11/1 5 /2 024 Logan Williams, Investigator SEE REVERSE Santos Camara, Investigator OF THIS PAGE Megan Ziegler, Investigator Joan Cantellops, Chemist
Observation 12 — Separate or defined areas to prevent contamination or mix-ups are deficient regarding
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the holding of rejected components, drug product containers and closures before disposition. Specifically, Drug Manufacturer Your firm failed to properly handle reject drug products. For the example, during the inspectional walktbrough of your Reject Room (Reject Cage), I found you did not have a logbook or a physical inventory in place of materials ~tore~d in be cape. Your Quality Assurance Manager, stated material stored in cage is verified (b) (4) !However, it is not documented nor there is written instructions forl (b) (4) n your procedure "Handling of Rejects, SOP- 000035 Doc Version: 4.0 Effective Date: 01 Aug 2024". Additionally, In-process rejects or finished rejects cannot be physically identified due to incorrect labels affixed on rejects. Your SOP lacks a defined list of reject materials that can be stored in the area. For example, Media Fill rejected samples were found in the area but not.
Observation 13 — Separate or defined areas to prevent contamination or mix-ups are deficient regarding
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the receipt, identification, storage, and withholding from use of components, drug product containers, and closures pending sampling, testing, or examination by the quality control unit before release for manufacturing or packaging. Specifically, Drug Manufacturer Your firm failed to record storage conditions during the receipt of Active Pharmaceutical Ingredients (APis). There is no assurance that drug substance has been kept under the right temperature conditions before and after receipt. During review of the Raw Material Disposition Report (FRM-000046 Doc Version: 12.0, Effective Date: 28 Dec 2023, Controlled Copy ID# CC-FRM-000046-- (b) (4) 1 found storage conditions are not indicated as required in the report. Warehouse operator stated that raw material is not received with a data logger and no time entry is recorded upon receipt of drug substance (only date). Manufacturer's label on raw material indicates raw material API should be kept refrigerated at- (b) (4)
Observation 14 — EMPLOYEE(S) SIGNATURE EMPLOYEE(S) NAME AND TITLE (Print or Type) DATE ISSUED 11
EMPLOYEE(S) SIGNATURE EMPLOYEE(S) NAME AND TITLE (Print or Type) DATE ISSUED 11 / 1 5/ 2024 Logan Williams, Investigator SEE REVERSE Santos Camara, Investigator OF THIS PAGE Megan Ziegler, Investigator Joan Cantellops, Chemist
Observation 15 — Written production and process control procedures are not followed in the execution
Written production and process control procedures are not followed in the execution of production and process control functions. Specifically, (b) (4) Your firm's process validation fo (b) (4) odium Injection 0.9%, USP were performed using .______ (b) (4)_ Chloride uct. There is no data to assure that the sterilization process is effective when the (b) (4) performed on compounded drug products. *DATES OF INSPECTION 11/04/2024 (Mon), 11/05/2024 (Tues), 11/06/2024 (Wed), l I /07/2024 (Thu), 11/08/2024 (Fri), 11/11/2024 (Mon), 11/12/2024 (Tues), 11 /13/2024 (Wed), 11/14/2024 (Thu), 11/15/2024 (Fri) SEE REVERSE OF THIS PAGE
Exela Pharma Sciences LLC’s FDA history
Argus HQ has recorded 1 total FDA action tied to Exela Pharma Sciences LLC: 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 Exela Pharma Sciences 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.
See if this 483 escalates to a warning letter — before your auditor asks.
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Related enforcement actions
Full FDA history for Exela Pharma Sciences 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 (2024). FDA Form 483 — Exela Pharma Sciences LLC (November 15, 2024) — 15 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-exela-pharma-sciences-llc-2024-11-15-3008563008
"FDA Form 483 — Exela Pharma Sciences LLC (November 15, 2024) — 15 Citations." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/483/fda-483-exela-pharma-sciences-llc-2024-11-15-3008563008.
Argus HQ Research. "FDA Form 483 — Exela Pharma Sciences LLC (November 15, 2024) — 15 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-exela-pharma-sciences-llc-2024-11-15-3008563008.
@misc{argushq_argushq_ai_483_fda_483_exela_pharma_sciences_llc_2024_11_15_3008563008_2024,
title = {FDA Form 483 — Exela Pharma Sciences LLC (November 15, 2024) — 15 Citations},
author = {{Argus HQ Research}},
year = {2024},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-exela-pharma-sciences-llc-2024-11-15-3008563008},
note = {Accessed: July 13, 2026}
}