FDA Inspection
FOCUS Laboratories, Inc.FOCUS Laboratories, Inc. – FDA Inspection, Sep 13, 2013
Record Details
This FDA Inspection record concerns FOCUS Laboratories, Inc., with an inspection on September 13, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- FOCUS Laboratories, Inc.
- Inspection Date
- September 13, 2013
- Product Type
- Drugs
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ID · 241325de-f5ad-4841-9f90-d85478aca31b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 848304
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
15- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- Failure of responsible person to report AE (non-RX Drug)
- 21 CFR 211.22(a)Contract drug products--lack of responsibility
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.170(b)Reserve drug product sample quantity - all tests
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(b)Tentative expiration date
- 21 CFR 111.75(c)(2)Specifications met - test, examinations; compliance
- 21 CFR 111.70(d)Specifications - labels, packaging
- 21 CFR 111.55Production, process controls - packaged, labeled
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Other FDA inspections of FOCUS Laboratories, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 24, 2021 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| August 28, 2018 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| May 22, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 26, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 6, 2015 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for FOCUS Laboratories, Inc.
- FDA Inspection 1137462 - 2021-03-24
- FDA Inspection 1066193 - 2018-08-28
- FDA Inspection 1053386 - 2018-05-22
- FDA Inspection 1051036 - 2018-04-26
- FDA Inspection 913332 - 2015-02-06
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