FDA Inspection
Prevention Health Sciences Inc.Prevention Health Sciences Inc. – FDA Inspection, Jan 26, 2018
Record Details
This FDA Inspection record concerns Prevention Health Sciences Inc., with an inspection on January 26, 2018, issued by the Chicago District Office, covering human drugs.
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ID · 64dabb2e-2bbe-45b6-a347-c0b891053b7b
Inspection Facts
- Inspection number
- 1038927
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
14- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.101(b)Identification of new containers
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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