FDA Inspection 850011 — Bioamazonic, Inc.
The FDA completed an inspection of Bioamazonic, Inc. on Oct 21, 2013 in Hialeah Gardens, FL. 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). 15 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 21, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hialeah Gardens, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16058 | 21 CFR 111.535(b)(2) | Records - ret'nd dietary supplement: material review, dispos |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |