FDA Inspection
Groupe Rocher Operations, SASGroupe Rocher Operations, SAS – FDA Inspection, Sep 9, 2016
Record Details
This FDA Inspection record concerns Groupe Rocher Operations, SAS, with an inspection on September 9, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 9, 2016
- Product Type
- Drugs
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ID · fa0c4875-f8bf-4ef6-9f4a-efc2cc97f460
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 986617
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
17- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.68(b)Backup file not maintained
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(3)Statement of Sample Weights and Measures
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.113(a)Procedures for non-sterile drug products
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