FDA Inspection
Unique Laboratories, Inc.Unique Laboratories, Inc. – FDA Inspection, May 4, 2011
Record Details
This FDA Inspection record concerns Unique Laboratories, Inc., with an inspection on May 4, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Unique Laboratories, Inc.
- Inspection Date
- May 4, 2011
- Product Type
- Drugs
View Company Profile
ID · b8e40b27-1bac-476e-a45b-96cdb82f0f4f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 724190
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
19- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.182Specific information required in individual logs
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.113(b)Procedures for sterile drug products
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