FDA Inspection
Ace Surgical Supply Co., Inc.Ace Surgical Supply Co., Inc. – FDA Inspection, Jul 23, 2015
Record Details
This FDA Inspection record concerns Ace Surgical Supply Co., Inc., with an inspection on July 23, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- July 23, 2015
- Product Type
- Biologics
View Company Profile
ID · e551c18c-4daa-4759-bbe5-d8070356e7cb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 941532
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 600.14(a)(1)Who must report - receiving information
- 21 CFR 820.90(a)Specific non-conforming product procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Ace Surgical Supply Co., Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 30, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 22, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 4, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 20, 2009 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Ace Surgical Supply Co., Inc.
- FDA Inspection 1090412 - 2019-04-30
- FDA Inspection 832771 - 2013-05-22
- FDA Inspection 723861 - 2011-05-04
- FDA Inspection 564132 - 2009-02-20
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.