FDA Inspection 1071844 — McDaniel Life-Line LLC
The FDA completed an inspection of McDaniel Life-Line LLC on November 16, 2018 in Dimmitt, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 16, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dimmitt, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18146 | 21 CFR 117.35(d) | Sanitation of food-contact surfaces - Frequency |
| 18149 | 21 CFR 117.40 | Equipment and utensils - Design and maintenance |
| 18154 | 21 CFR 117.80(a)(2) | Appropriate quality control operations |
| 18157 | 21 CFR 117.80(b)(2) | Raw materials control - Microorganisms |
| 18162 | 21 CFR 117.80(c) | Process Control Measures |
| 18397 | 21 CFR 117.4 | Qualifications of individuals |