Arca
Skip to content

Creative Foam Corporation - Bremen

FDA establishment 3001814065, Bremen, Indiana, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.

  • Inspections: 1
  • Official action indicated: 0
  • Last inspection ended: Nov 24, 2025
  • Warning letters: 0

Inspections by Fiscal Year

FY2018 to FY2027 to date; 0 classified OAI

Inspections

1 inspections, newest first
EndedProduct and areaCitationsClassification
Nov 24, 2025Devices · Compliance: Devices
8 cited references
  • 21 CFR 820.250(b). Sampling plans Sampling plans are not written and based on valid statistical rationale.
  • 21 CFR 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
  • 21 CFR 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures have not been adequately established to control product that does not conform to specified requirements.
  • 21 CFR 820.72(a). Calibration, Inspection, etc. Procedures Lack of or Inadequ Procedures to ensure equipment is routinely calibrated have not been adequately established.
  • 21 CFR 820.70(g)(1). Maintenance schedule, Lack of or inadequate schedule Schedules for the adjustment, cleaning, and other maintenance of equipment have not been adequately established.
  • 21 CFR 820.75(b). Lack/Inad procedure-Monitoring/Control of Validated Proces Procedures for monitoring and control of process parameters for a validated process have not been adequately established.
  • 21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
  • 21 CFR 820.75(a). Lack of or inadequate process validation A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
Voluntary Action Indicated (VAI)

Identifiers

FEI number
3001814065
FDA firm profile
Data Dashboard

An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard and warning letters

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.