Form FDA 483 · Issued 2026-02-20
Staska Pharmaceuticals, Inc — FDA Form 483 Analysis
FEI: 3017473850 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Outsourcing Facility) · Lead Investigator: David K. Chen
FDA Form 483 issued to Staska Pharmaceuticals, Inc (FEI 3017473850) on 2026-02-20 following an inspection of its outsourcing facility operations in Nebraska. The report documents 4 inspection observations centered on Cleaning Validation, Sanitation Logs & Pest Control, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
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Observation-by-Observation 21 CFR Breakdown (4)
Observation #1 · 21 CFR 211.67(b)(2)
Cleaning Validation, Sanitation Logs & Pest Control
REPEAT CITATION AT FACILITY
Cleaning SOPs/schedules
Inspector Observation Language: "Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules. Specifically, observed during inspection of Staska Pharmaceuticals, Inc on 2026-02-20."
Plain-English Meaning: Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
Standard CAPA Remediation Path: Implement lot-linked equipment cleaning verification logs with QA sign-off before line clearance, ATP/allergen swabbing after shared-line runs, and weekly documented pest-control inspections.
Observation #2 · 21 CFR 211.42(c)(10)(iii)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Air Supply
Inspector Observation Language: "Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure. Specifically, observed during inspection of Staska Pharmaceuticals, Inc on 2026-02-20."
Plain-English Meaning: Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
Standard CAPA Remediation Path: Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention.
Observation #3 · 21 CFR 211.166(a)(1)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Sample size - test intervals
Inspector Observation Language: "The written stability program for drug products does not include [sample size] [test intervals] based on statistical criteria for each attribute examined to assure valid estimates of stability. Specifically, observed during inspection of Staska Pharmaceuticals, Inc on 2026-02-20."
Plain-English Meaning: Releasing finished batches without verifying strength/potency/microbiological specs, or placing an expiration/best-by date on labels without supporting real-time or accelerated stability data.
Standard CAPA Remediation Path: Require finished-batch microbiological (USP <2021>/<2022>), heavy metal, and active-assay release testing plus ICH stability chamber protocols supporting every label shelf-life claim.
Observation #4 · 21 CFR 211.186(a)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Written procedures followed
Inspector Observation Language: "Procedures for the preparation of master production and control records are not [described in a written procedure] [followed]. Specifically, observed during inspection of Staska Pharmaceuticals, Inc on 2026-02-20."
Plain-English Meaning: Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
Standard CAPA Remediation Path: Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention.