FDA Inspection 755447 — Healz-Plus, Inc.
The FDA completed an inspection of Healz-Plus, Inc. on Nov 29, 2011 in Sulphur, LA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 19 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 29, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sulphur, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1541 | 21 CFR 211.125(b) | Examination of issued labels |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1724 | 21 CFR 211.134(b) | Representative samples after completion |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1797 | 21 CFR 211.82(a) | Examination on receipt, before acceptance |
| 1798 | 21 CFR 211.82(b) | Quarantine Storage of Components |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |