FDA Inspection
Pharmalogic Puerto Rico IncPharmalogic Puerto Rico Inc – FDA Inspection, Aug 21, 2026
Record Details
This FDA Inspection record concerns Pharmalogic Puerto Rico Inc, with an inspection on August 21, 2026, issued by the San Juan District Office, covering human drugs.
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ID · b1d34ff8-0b13-4b42-b17e-d3c091d2f2ee
Inspection Facts
- Inspection number
- 1332010
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 212.20(d)Determination need for investigation
- 21 CFR 212.30(b)Equipment procedures
- 21 CFR 212.40(c)Use of reliable suppliers
- 21 CFR 212.50(a)Written control procedures
- 21 CFR 212.60(d)Supplies adequately controlled
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Other FDA inspections of Pharmalogic Puerto Rico Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 19, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 22, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 27, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Pharmalogic Puerto Rico Inc
- FDA Inspection 1041773 - 2018-01-19
- FDA Inspection 979345 - 2016-07-22
- FDA Inspection 860324 - 2013-12-27
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