FDA Inspection
Delta Laboratories Pty LtdDelta Laboratories Pty Ltd – FDA Inspection, Mar 31, 2017
Record Details
This FDA Inspection record concerns Delta Laboratories Pty Ltd, with an inspection on March 31, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · bf5dcfde-dda9-4124-9261-0ededd4461a6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1009269
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 211.188(b)(11)Identification of persons involved, each significant step
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(4)Data secured in course of each test
- 21 CFR 211.165(f)Reprocessed drug products not meeting acceptance criteria
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
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