FDA Inspection
Howard Phillips LLC dba Phillips Co.Howard Phillips LLC dba Phillips Co. – FDA Inspection, Oct 7, 2016
Record Details
This FDA Inspection record concerns Howard Phillips LLC dba Phillips Co., with an inspection on October 7, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 03391699-b883-4c12-bcaa-d16cca8b6706
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 987780
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.82(b)Quarantine Storage of Components
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
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Other FDA inspections of Howard Phillips LLC dba Phillips Co.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 11, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 9, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Howard Phillips LLC dba Phillips Co.
- FDA Inspection 980708 - 2016-08-11
- FDA Inspection 588186 - 2009-06-09
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