FDA Inspection
Cunningpac CCCunningpac CC – FDA Inspection, Dec 7, 2018
Record Details
This FDA Inspection record concerns Cunningpac CC, with an inspection on December 7, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b9ed74ad-9f2a-49eb-ab08-928d29a13e9e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1074309
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.182Written records kept in individual logs
- 21 CFR 211.186(a)Master production and control records, batch uniformity
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