Key facts
| Firm | Stokes Healthcare Inc. dba Epicur Pharma |
|---|---|
| FEI / inspection ID | 3002815949 |
| Inspection end date | May 23, 2025 |
| Citation count | 5 |
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 — 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. This is a repeat observation. Specifically, A. Your firm released several batches of Tacrolimus AQ Ophthalmic Suspension (without labeling them for veterinary use) and other veterinary products intended to be sterile, despite the detection of microbial growth during personnel monitoring (PM) and environmental monitoring (EM) within the ISO 5 production area since October 2023. Your firm has identified positive microbial growth during the EM/PM activities associated with the production of Tacrolimus AQ Ophthalmic Suspension (without labeling them for veterinary use), described as follows: • MIR-010-2023: Tacrolimus AQ 0.02% Ophthalmic Suspension, Lot# R230600 - 2 CFUs of Hansfordia sinuosae (a mold) were identified on the operator's right gloved hand. Date Occurred: 10/6/2023. • MIR-005-2024: Tacrolimus AQ 0.03% Ophthalmic Suspension, Lot# R240103 - 1 CFU of Streptomyces tendae/tritolerans was identified on the left wall within the ISO 5 aseptic EMPI.OYEE(S) SIGNATURE DATE ISSUED.
Observation 2 — Aseptic processing areas are deficient regarding the system for cleaning and disinfecting
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions. This is a repeat observation. Specifically, A. The sporicidal agent used to clean the ISO 5 aseptic area did not meet the contact time specified in the cleaning SOP. According to SOP SC-SAN-1010 Cleaning and Maintenance of the Aseptic Manufacturing Area, Revision 2.00, Effective Date: 7/29/2024 l(l5) (4) !surface contact time has been established fo ~6H4) !however, camera footage dated 5/12/2025 shows that during the cleaning of the ISO 5 aseptic processing area immediately following the production of Tacrolimus AQ 0.5% (10 mL), Lot [(l:>)(4) I in Room 706, the operator applied [{6f(4 l at 10:16:59 and wiped it with a mop pre-saturated with!(6r(4) I at 10 :2 1: 41 - resulting in a contact time of less than 5 minutes. B. The camera footage dated 5/ 12/2025 shows that the operator did not thoroughly disinfect racks containing wells used to hold.
Observation 3 — Your firm failed to establish adequate written procedures for production and process
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. This is a repeat observation. Specifically, The process validation for the Tacrolimus eye drops has not established critical control parameters. □ . b • "d (6) 4 During the aseptic filling ofTacrolimus eye drops, strr ar ms1 e lvesse [(5) (4) !stirs the bulk suspension product to maintain uniformity. However, the frrm has not established an acceptable operating range for the stir bar speed. For example, the stir bar speed settings for two different batches ofTacrolimus AQ 1% Ophthalmic Suspension (Lot# 250197 and Lot# 250227) were l(b) (4) land (b) (4 p,n,i:~respectively without an established acceptable range. Since 2024, your frrm has reported 19 out- of-specification (OOS) batches ofTacrolimus eye drops. Of those, 9 batches had confrrmed OOS results and were rejected, but no definitive.
Observation 4 — 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, Your stability study failed to test for impurities of Tacrolimus Ophthalmic Suspension including :( 6r(4) I individual unspecified impurities and total impurities as specified in the finished product specifications. For example, your firm failed to test for any of these impurities during the K6) (4) !stability study for Tacrolimus AQ 0.02% Ophthalmic Suspension, Lot# R230428 8/22/2023 and th [( 6) (4) !stability study for Tacrolimus AQ 0.02% Ophthalmic Suspension, Lot# R230428, initiated on 8/22/2023. Impurities are tested at the time of product release; however, there is no assurance that impurity levels will remain within specification through the product's expiration date. Your firm manufactures approximately LJ batches of Tacrolimus Ophthalmic Suspension pe l(6) (4) lin Room 706.
Observation 5 — 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 conform to appropriate standards of identity, strength, quality and purity. EMPI.OYEE(S) SIGNATURE DATE ISSUED SEE REVERSE Ta i c hun Qin , I nves tig a to r 5 / 2 3/ 2025 OF THIS PAGE -:.-:~Tllc:tunan t t, ~·8yJ~f~~ X °' "' FORM FDA 433 (09/ 08) PREMOUS EDmONOBSOLErrE INSPECTION AL OBSERVATIONS PAGE 5 of 6 PAGE S
Stokes Healthcare Inc. dba Epicur Pharma’s FDA history
Argus HQ has recorded 1 total FDA action tied to Stokes Healthcare Inc. dba Epicur Pharma: 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 Stokes Healthcare Inc. dba Epicur Pharma 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.
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Related enforcement actions
Full FDA history for Stokes Healthcare Inc. dba Epicur PharmaCompiled 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). Stokes Healthcare Inc. dba Epicur Pharma — FDA Form 483 Inspection, May 23, 2025 (5 Citations). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-stokes-healthcare-inc-dba-epicur-pharma-2025-05-23-3002815949
"Stokes Healthcare Inc. dba Epicur Pharma — FDA Form 483 Inspection, May 23, 2025 (5 Citations)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-stokes-healthcare-inc-dba-epicur-pharma-2025-05-23-3002815949.
Argus HQ Research. "Stokes Healthcare Inc. dba Epicur Pharma — FDA Form 483 Inspection, May 23, 2025 (5 Citations)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-stokes-healthcare-inc-dba-epicur-pharma-2025-05-23-3002815949.
@misc{argushq_argushq_ai_483_fda_483_stokes_healthcare_inc_dba_epicur_pharma_2025_05_23_3002815949_2025,
title = {Stokes Healthcare Inc. dba Epicur Pharma — FDA Form 483 Inspection, May 23, 2025 (5 Citations)},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-stokes-healthcare-inc-dba-epicur-pharma-2025-05-23-3002815949},
note = {Accessed: July 13, 2026}
}