FDA Inspection
HD Medical Services (India) Private LimitedHD Medical Services (India) Private Limited – FDA Inspection, Aug 12, 2014
Record Details
This FDA Inspection record concerns HD Medical Services (India) Private Limited, with an inspection on August 12, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 12, 2014
- Product Type
- Devices
View Company Profile
ID · c420f923-936b-4ea1-9c52-f3f3ca6e3a0d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 893721
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
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.