Form FDA 483 · Issued 2025-12-11
Hatch Product Development LLC — FDA Form 483 Analysis
FEI: 3030438338 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Contract Manufacturer & Distributor) · Lead Investigator: Thomas W. Halvorsen
FDA Form 483 issued to Hatch Product Development LLC (FEI 3030438338) on 2025-12-11 following an inspection of its contract manufacturer & distributor operations in Illinois. The report documents 3 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · FDCA 501(a)(2)(A)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
REPEAT CITATION AT FACILITY
Sporicidal agent, ISO 5/classified areas
Inspector Observation Language: "Use of a sporicidal agent in the facility's [ISO 5 areas] [classified areas] was [lacking] [improper] [infrequent]. Specifically, observed during inspection of Hatch Product Development LLC on 2025-12-11."
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 #2 · FDCA 503B(a)(10)(B)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Drug product container, fails to include
Inspector Observation Language: "The container of your outsourcing facility's drug products does not include information required by section 503B(a)(10)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, observed during inspection of Hatch Product Development LLC on 2025-12-11."
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 211.67(b)(6)
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
Cleaning SOP/inspection
Inspector Observation Language: "Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use. Specifically, observed during inspection of Hatch Product Development LLC on 2025-12-11."
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.