FDA Inspection
Bureau Veritas Consumer Products Services Inc.Bureau Veritas Consumer Products Services Inc. – FDA Inspection, Feb 1, 2018
Record Details
This FDA Inspection record concerns Bureau Veritas Consumer Products Services Inc., with an inspection on February 1, 2018, issued by the New York District Office, covering human drugs.
- Inspection Date
- February 1, 2018
- Product Type
- Human Drugs
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ID · 844f7fd3-3bd1-4417-9bda-260c341c6b16
Inspection Facts
- Inspection number
- 1039343
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.170(a)(3)Retention times for actives of OTC drugs
- 21 CFR 211.194(c)Testing and standardization of standards et. al.
- 21 CFR 211.22(a)Contract drug products--lack of responsibility
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.68(b)input/output verification
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