Form FDA 483 · Issued 2026-03-26
Cosmetics & Cleaners International LLC — FDA Form 483 Analysis
FEI: 3009878984 · Sector: Cosmetics & Skincare (Producer of Regulated Products) · Lead Investigator: Sarah J. Lindqvist
FDA Form 483 issued to Cosmetics & Cleaners International LLC (FEI 3009878984) on 2026-03-26 following an inspection of its producer of regulated products operations in North Carolina. The report documents 5 inspection observations centered on CAPA, Out-of-Specification (OOS) & Complaint Investigations.
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · FD&C Act Sec. 605 / MoCRA Serious Adverse Event
CAPA, Out-of-Specification (OOS) & Complaint Investigations
FIRST-TIME OBSERVATION
Failure to maintain 15-day Serious Adverse Event reporting & label contact address
Inspector Observation Language: "Responsible person failed to maintain records of adverse events and submit serious adverse event reports within 15 business days, or product label omitted domestic address, phone number, or electronic contact information for adverse event receipt."
Plain-English Meaning: Failure to thoroughly investigate unexplained batch discrepancies, Out-of-Specification lab results, or consumer complaints/adverse events and document root-cause Corrective and Preventive Actions (CAPA).
Standard CAPA Remediation Path: Deploy a closed-loop CAPA and OOS investigation SOP requiring root-cause determination within 30 business days, impact assessment on distributed lots, and effectiveness checks.
Observation #2 · FD&C Act Sec. 605 / MoCRA Serious Adverse Event
CAPA, Out-of-Specification (OOS) & Complaint Investigations
REPEAT CITATION AT FACILITY
Failure to maintain 15-day Serious Adverse Event reporting & label contact address
Inspector Observation Language: "Responsible person failed to maintain records of adverse events and submit serious adverse event reports within 15 business days, or product label omitted domestic address, phone number, or electronic contact information for adverse event receipt."
Plain-English Meaning: Failure to thoroughly investigate unexplained batch discrepancies, Out-of-Specification lab results, or consumer complaints/adverse events and document root-cause Corrective and Preventive Actions (CAPA).
Standard CAPA Remediation Path: Deploy a closed-loop CAPA and OOS investigation SOP requiring root-cause determination within 30 business days, impact assessment on distributed lots, and effectiveness checks.
Observation #3 · FD&C Act Sec. 605 / MoCRA Serious Adverse Event
CAPA, Out-of-Specification (OOS) & Complaint Investigations
FIRST-TIME OBSERVATION
Failure to maintain 15-day Serious Adverse Event reporting & label contact address
Inspector Observation Language: "Responsible person failed to maintain records of adverse events and submit serious adverse event reports within 15 business days, or product label omitted domestic address, phone number, or electronic contact information for adverse event receipt."
Plain-English Meaning: Failure to thoroughly investigate unexplained batch discrepancies, Out-of-Specification lab results, or consumer complaints/adverse events and document root-cause Corrective and Preventive Actions (CAPA).
Standard CAPA Remediation Path: Deploy a closed-loop CAPA and OOS investigation SOP requiring root-cause determination within 30 business days, impact assessment on distributed lots, and effectiveness checks.
Observation #4 · FD&C Act Sec. 605 / MoCRA Serious Adverse Event
CAPA, Out-of-Specification (OOS) & Complaint Investigations
FIRST-TIME OBSERVATION
Failure to maintain 15-day Serious Adverse Event reporting & label contact address
Inspector Observation Language: "Responsible person failed to maintain records of adverse events and submit serious adverse event reports within 15 business days, or product label omitted domestic address, phone number, or electronic contact information for adverse event receipt."
Plain-English Meaning: Failure to thoroughly investigate unexplained batch discrepancies, Out-of-Specification lab results, or consumer complaints/adverse events and document root-cause Corrective and Preventive Actions (CAPA).
Standard CAPA Remediation Path: Deploy a closed-loop CAPA and OOS investigation SOP requiring root-cause determination within 30 business days, impact assessment on distributed lots, and effectiveness checks.
Observation #5 · FD&C Act Sec. 605 / MoCRA Serious Adverse Event
CAPA, Out-of-Specification (OOS) & Complaint Investigations
FIRST-TIME OBSERVATION
Failure to maintain 15-day Serious Adverse Event reporting & label contact address
Inspector Observation Language: "Responsible person failed to maintain records of adverse events and submit serious adverse event reports within 15 business days, or product label omitted domestic address, phone number, or electronic contact information for adverse event receipt."
Plain-English Meaning: Failure to thoroughly investigate unexplained batch discrepancies, Out-of-Specification lab results, or consumer complaints/adverse events and document root-cause Corrective and Preventive Actions (CAPA).
Standard CAPA Remediation Path: Deploy a closed-loop CAPA and OOS investigation SOP requiring root-cause determination within 30 business days, impact assessment on distributed lots, and effectiveness checks.