FDA Inspection
EnviroServe Chemicals Inc.EnviroServe Chemicals Inc. – FDA Inspection, Sep 17, 2024
Record Details
This FDA Inspection record concerns EnviroServe Chemicals Inc., with an inspection on September 17, 2024, issued by the Atlanta District Office, covering human drugs.
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ID · 0d4264eb-b731-47a0-8dfe-db96bf39efd5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1249434
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
- 21 CFR 211.196Distribution Record Requirements
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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