FDA Inspection 769052 — Teleflex Medical De Tecate, S. De R.L De C.V. (A Teleflex Medical Company)

Teleflex Medical De Tecate, S. De R.L De C.V. (A Teleflex Medical Company) — FEI 3003898360

The FDA completed an inspection of Teleflex Medical De Tecate, S. De R.L De C.V. (A Teleflex Medical Company) on Jan 12, 2012 in Tecate. 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). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Jan 12, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
Tecate (Mexico)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures