FDA Inspection
Primary Health Care AssociatesPrimary Health Care Associates – FDA Inspection, Jan 25, 2012
Record Details
This FDA Inspection record concerns Primary Health Care Associates, with an inspection on January 25, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- January 25, 2012
- Product Type
- Biologics
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ID · 636cad9f-e632-4edf-b5d8-88599d5074dc
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 764439
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
7- 21 CFR 1271.160(a)All core requirements covered in program
- 21 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.150(c)(1)(iii)Ensurane of compliance
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Primary Health Care Associates
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 30, 2019 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 4, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 11, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 7, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Primary Health Care Associates
- FDA Inspection 1091896 - 2019-05-30
- FDA Inspection 1016982 - 2017-05-04
- FDA Inspection 917618 - 2015-03-11
- FDA Inspection 807054 - 2012-11-07
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