FDA Inspection
McDaniel Life-Line LLCMcDaniel Life-Line LLC – FDA Inspection, Nov 16, 2018
Record Details
This FDA Inspection record concerns McDaniel Life-Line LLC, with an inspection on November 16, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Shelby N. Turner (Investigator)
- Travis Brown (Issuing Officer)
View Company Profile
ID · bb457255-c62e-484f-aa66-ca0da1c93394
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1071844
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 117.35(d)Sanitation of food-contact surfaces - Frequency
- 21 CFR 117.4Qualifications of individuals
- 21 CFR 117.80(b)(2)Raw materials control - Microorganisms
- 21 CFR 117.80(a)(2)Appropriate quality control operations
- 21 CFR 117.80(c)Process Control Measures
- 21 CFR 117.40Equipment and utensils - Design and maintenance
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