FDA Inspection
Mid-Atlantic Surgical Systems, LLCMid-Atlantic Surgical Systems, LLC – FDA Inspection, Mar 30, 2016
Record Details
This FDA Inspection record concerns Mid-Atlantic Surgical Systems, LLC, with an inspection on March 30, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 30, 2016
- Product Type
- Biologics
View Company Profile
ID · 2234ea99-f44d-4297-a9ff-6d5b9aee59d0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 972651
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
6- 21 CFR 1271.180(d)Adopted from another organization
- 21 CFR 1271.195(d)Documentation not maintained
- 21 CFR 1271.160(c)Quality audits performed periodically
- 21 CFR 1271.265(f)Return to inventory--procedures
- 21 CFR 1271.160(b)(6)Deviations--Investigation, documenting, trending
- 21 CFR 1271.160(b)(1)Ensuring appropriate core requirements followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Mid-Atlantic Surgical Systems, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 30, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 9, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 18, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 21, 2011 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Mid-Atlantic Surgical Systems, LLC
- FDA Inspection 1173785 - 2022-06-30
- FDA Inspection 1066715 - 2018-08-09
- FDA Inspection 866375 - 2014-02-18
- FDA Inspection 759509 - 2011-12-21
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.