FDA Inspection 754506 — Dhaliwal Labs South LLC
The FDA completed an inspection of Dhaliwal Labs South LLC on December 15, 2011 in Dallas, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 20 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 15, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3569 | 21 CFR 211.89 | Quarantine of Rejected Components et. al. |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |