FDA Inspection
Northeast Laboratories, Inc.Northeast Laboratories, Inc. – FDA Inspection, Mar 29, 2017
Record Details
This FDA Inspection record concerns Northeast Laboratories, Inc., with an inspection on March 29, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 3f5a1487-d4ea-4559-a8b5-8e94fb9f1696
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1006525
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.194(a)(8)Identification of Person Performing Review of Lab Records
- 21 CFR 211.194(a)(2)Reference and method not stated
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Northeast Laboratories, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 11, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 2, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 4, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Northeast Laboratories, Inc.
- FDA Inspection 1229261 - 2024-01-11
- FDA Inspection 755765 - 2011-12-02
- FDA Inspection 643538 - 2010-02-04
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