FDA Inspection 927285 — Mettler-Toledo, LLC
The FDA completed an inspection of Mettler-Toledo, LLC on May 22, 2015 in Tampa, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 22, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5034 | 21 CFR 1010.2(c) | Certification not based on adequate test/testing program |
| 5043 | 21 CFR 1010.3(a)(1) | ID label lacks name and address |
| 5046 | 21 CFR 1010.3(a)(2)(ii) | Manufacture date abbreviated or unapproved date coding |
| 5071 | 21 CFR 1020.40(c)(4)(i) | Multiple interlocks on doors |
| 5073 | 21 CFR 1020.40(c)(4)(i) | Door interlock dependent upon moving part other than door |
| 5082 | 21 CFR 1020.40(c)(6)(iii) | Exposure indication - two independent means |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |
| 5812 | 21 CFR 1002.30(a)(2) | Results of tests |