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590063

Bausch & Lomb Incorporated — FEI 1032500

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
May 12, 2009
Fiscal Year
2009
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Greenville, SC (United States)

Facility

Other inspections at this facility

  • 1250877 (OAI Thu Feb 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1073462 (NAI Tue Aug 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1031429 (NAI Fri Sep 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 988726 (VAI Wed Oct 05 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 911396 (NAI Thu Jan 15 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
230221 CFR 820.20(e)Quality System Procedures
243021 CFR 820.30(b)Design plans - Lack of or inadequate
328821 CFR 820.90(b)(1)Documentation of disposition, justification, signature
330421 CFR 820.100(a)(5)Changes to correct/prevent quality problems
335521 CFR 820.198(f)Records accessibility
341621 CFR 820.70(a)(1)Process control instructions
369021 CFR 820.100(a)(3)Identification of actions needed
369221 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
369621 CFR 820.100(b)Documentation
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures