FDA Inspection
General Hospital Corporation (The)General Hospital Corporation (The) – FDA Inspection, Jun 17, 2019
Record Details
This FDA Inspection record concerns General Hospital Corporation (The), with an inspection on June 17, 2019, issued by the New England District Office, covering human drugs.
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ID · db11e25c-8bc5-4298-a47d-fb1f779c42e4
Inspection Facts
- Inspection number
- 1094535
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 212.10Personnel not qualified
- 21 CFR 212.20(e)Written QA procedures established, followed
- 21 CFR 212.30(a)Orderly handling, prevention of mix-ups, prevention of contamination
- 21 CFR 212.30(b)Equipment procedures
- 21 CFR 212.80(d)Labeling and product mix-ups
- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
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Other FDA inspections of General Hospital Corporation (The)
7| Date | Classification | Office | Project area |
|---|---|---|---|
| May 23, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 23, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 31, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 24, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 20, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for General Hospital Corporation (The)
- FDA Inspection 1241625 - 2024-05-23
- FDA Inspection 1110333 - 2019-10-23
- FDA Inspection 1042063 - 2018-01-31
- FDA Inspection 999897 - 2017-01-24
- FDA Inspection 992257 - 2016-10-20
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