FDA Inspection
Pharmasol CorporationPharmasol Corporation – FDA Inspection, Aug 20, 2018
Record Details
This FDA Inspection record concerns Pharmasol Corporation, with an inspection on August 20, 2018, issued by the New England District Office, covering human drugs.
- People
- Jonathan G. Matrisciano (FDA Associated Person)
- Margaret M. Doherty (Issuing Officer)
- Sean R. Marcsisin (FDA Associated Person)
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ID · cbed2c53-5e85-4e38-948e-30bde579e8c3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1062647
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.122(a)Written procedures not followed
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.84(b)Representative Samples
- 21 CFR 820.20(c)Management review dates
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Other FDA inspections of Pharmasol Corporation
7| Date | Classification | Office | Project area |
|---|---|---|---|
| June 14, 2021 | OAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| August 4, 2016 | NAI | Center for Drug Evaluation and Research | Postmarket Surv. and Epidemiology |
| July 16, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 30, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 30, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Pharmasol Corporation
- FDA Inspection 1143828 - 2021-06-14
- FDA Inspection 982568 - 2016-08-04
- FDA Inspection 936866 - 2015-07-16
- FDA Inspection 902345 - 2014-10-30
- FDA Inspection 853366 - 2013-10-30
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