FDA Inspection 1072072 — McDaniel Life-Line LLC
The FDA completed an inspection of McDaniel Life-Line LLC on Nov 16, 2018 in Felt, OK. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Nov 16, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Felt, OK (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1632 | 21 CFR 211.130(c) | Lot or control number assigned |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |