FDA Inspection
Deserving Health International CorpDeserving Health International Corp – FDA Inspection, Jul 14, 2017
Record Details
This FDA Inspection record concerns Deserving Health International Corp, with an inspection on July 14, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · cf9f0c92-3f16-4259-9549-467a16a89664
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1018490
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
20- 21 CFR 211.122(d)Label storage access limited to authorized personnel
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.160(a)Lab controls established, including changes
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