FDA Inspection
Pharmatech LLCPharmatech LLC – FDA Inspection, Aug 9, 2016
Record Details
This FDA Inspection record concerns Pharmatech LLC, with an inspection on August 9, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Pharmatech LLC
- Inspection Date
- August 9, 2016
- Product Type
- Drugs
View Company Profile
ID · c328cee0-9687-437c-b02e-74365ee76316
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 981451
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 111.560(a)(2)Product complaint - quality control investigate
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
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Other FDA inspections of Pharmatech LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 2, 2017 | 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 1011327 - 2017-05-02
- FDA Inspection 965401 - 2016-03-02
- FDA Inspection 768951 - 2012-01-24
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