FDA Inspection
Pharmatech LLCPharmatech LLC – FDA Inspection, May 2, 2017
Record Details
This FDA Inspection record concerns Pharmatech LLC, with an inspection on May 2, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · fd03530c-6b1c-4cbe-a2f8-4de7077d25c3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1011327
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 111.560(a)(2)Product complaint - quality control investigate
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 111.75(b)(2)Specifications met - deviation, unanticipated occurrence
- 21 CFR 111.415Fill, assemble, package, label - quality
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Other FDA inspections of Pharmatech LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 9, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 2, 2016 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| January 24, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Pharmatech LLC
- FDA Inspection 981451 - 2016-08-09
- FDA Inspection 965401 - 2016-03-02
- FDA Inspection 768951 - 2012-01-24
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