FDA Inspection
Greatbatch Medical S. De R.L. De C.V.Greatbatch Medical S. De R.L. De C.V. – FDA Inspection, Aug 15, 2019
Record Details
This FDA Inspection record concerns Greatbatch Medical S. De R.L. De C.V., with an inspection on August 15, 2019, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 2c89199e-66c4-47bf-a793-5706f4dee807
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1099650
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Greatbatch Medical S. De R.L. De C.V.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 2, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 26, 2018 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
Other documents for Greatbatch Medical S. De R.L. De C.V.
- FDA Inspection 1199725 - 2023-02-02
- FDA Inspection 1062662 - 2018-07-26
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.