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Bio Protech Yantai Inc.

FDA establishment 3010805941, Yantai, China. Every inspection FDA has posted for the site, with its outcome and cited regulations.

  • Inspections: 2
  • Official action indicated: 1
  • Last inspection ended: Mar 13, 2025
  • Warning letters: 0

Inspections by Fiscal Year

FY2018 to FY2027 to date; 1 classified OAI

Most Cited at This Site

Inspections citing each reference

Inspections

2 inspections, newest first
EndedProduct and areaCitationsClassification
Mar 13, 2025Devices · Compliance: Devices
5 cited references
  • 21 CFR 820.75(a). Documentation Process validation activities have not been documented and adequately documented.
  • 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 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
  • 21 CFR 820.70(c). Environmental control Lack of or inadequate procedures Procedures to control environmental conditions have not been adequately established.
  • 21 CFR 820.86. Acceptance status The acceptance status of product was not maintained.
Official Action Indicated (OAI)
Mar 25, 2016Devices · Compliance: DevicesNone postedNo Action Indicated (NAI)

Identifiers

FEI number
3010805941
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.