FDA Inspection
Mettler-Toledo, LLCMettler-Toledo, LLC – FDA Inspection, May 22, 2015
Record Details
This FDA Inspection record concerns Mettler-Toledo, LLC, with an inspection on May 22, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Mettler-Toledo, LLC
- Inspection Date
- May 22, 2015
- Product Type
- Devices
View Company Profile
ID · 30638277-7c6d-4224-ad7f-7ce195b0aaf4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 927285
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
9- 21 CFR 1020.40(c)(4)(i)Multiple interlocks on doors
- 21 CFR 1020.40(c)(4)(i)Door interlock dependent upon moving part other than door
- 21 CFR 1010.3(a)(1)ID label lacks name and address
- 21 CFR 1010.2(c)Certification not based on adequate test/testing program
- 21 CFR 1020.40(c)(6)(iii)Exposure indication - two independent means
- 21 CFR 1010.3(a)(2)(ii)Manufacture date abbreviated or unapproved date coding
- 21 CFR 1002.13Failure to submit
- 21 CFR 1002.10Failure to submit, distinct marking
- 21 CFR 1002.30(a)(2)Results of tests
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