FDA Inspection
Diamond Institute for Infertility and MenopauseDiamond Institute for Infertility and Menopause – FDA Inspection, Jul 6, 2016
Record Details
This FDA Inspection record concerns Diamond Institute for Infertility and Menopause, with an inspection on July 6, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- July 6, 2016
- Product Type
- Biologics
View Company Profile
ID · b0e85e15-eace-49ea-9f62-6edb18ef1405
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 979157
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
11- 21 CFR 1271.85(b)(2)SOP for release; reactive for CMV
- 21 CFR 1271.47(b)Review and approval of procedures
- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.65(c)Nonclinical use--label requirements
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
- 21 CFR 1271.55(c)Name and personal info on accompanying records
- 21 CFR 1271.50(a)Responsible person to determine, document
- 21 CFR 1271.55(b)(1)Statement re: certified testing lab
Showing 10 of 11 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Diamond Institute for Infertility and Menopause
7| Date | Classification | Office | Project area |
|---|---|---|---|
| February 22, 2023 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| February 23, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| July 6, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 6, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 24, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Diamond Institute for Infertility and Menopause
- FDA Inspection 1198058 - 2023-02-22
- FDA Inspection 1162967 - 2022-02-23
- FDA Inspection 1059272 - 2018-07-06
- FDA Inspection 860557 - 2013-12-06
- FDA Inspection 784052 - 2012-05-24
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.