FDA Inspection
Harvard Chemical, LLCHarvard Chemical, LLC – FDA Inspection, Mar 28, 2016
Record Details
This FDA Inspection record concerns Harvard Chemical, LLC, with an inspection on March 28, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Harvard Chemical, LLC
- Inspection Date
- March 28, 2016
- Product Type
- Drugs
View Company Profile
ID · e23f56e1-3687-4deb-8464-e4003b645d61
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 988556
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.170(a)Active ingredient retained sample kept
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.84(d)(2)Component identification test
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.198(a)Reporting of adverse drug experience to FDA
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