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
- Charles D. Brown (FDA Associated Person)
- Margaret M. Annes (FDA Associated Person)
- Shelby N. Turner (Investigator)
- Travis Brown (Issuing Officer)
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ID · 4f58575b-db64-4960-9f5a-de12b430e620
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1072072
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
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 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.130(c)Lot or control number assigned
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up
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