FDA Inspection
Primary Health Care AssociatesPrimary Health Care Associates – FDA Inspection, May 30, 2019
Record Details
This FDA Inspection record concerns Primary Health Care Associates, with an inspection on May 30, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · f83201bd-e2f7-49ff-87a4-d1830faea3da
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1091896
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.55(b)(3)Name and address on summary
- 21 CFR 1271.55(b)(4)Reasons for ineligibility on summary
- 21 CFR 1271.150(c)(1)(iii)Ensurane of compliance
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Other FDA inspections of Primary Health Care Associates
4| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| January 25, 2012 | OAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Primary Health Care Associates
- FDA Inspection 1016982 - 2017-05-04
- FDA Inspection 917618 - 2015-03-11
- FDA Inspection 807054 - 2012-11-07
- FDA Inspection 764439 - 2012-01-25
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