FDA Inspection 764662 — Linpharma Inc.
The FDA completed an inspection of Linpharma Inc. on Jan 19, 2012 in Tampa, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 19, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15529 | 21 CFR 111.30(e) | Equipment - controls, intended use |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15548 | 21 CFR 111.260(h) | Batch record - results; testing, examination; batch |
| 15549 | 21 CFR 111.260(i) | Batch record - specifications |
| 15555 | 21 CFR 111.260(j)(2)(iii) | Batch record - initials; component |
| 15556 | 21 CFR 111.260(j)(2)(iv) | Batch record - initials; verifying component |
| 15566 | 21 CFR 111.260(l)(3) | Batch record - approved, released, rejected; batch |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15786 | 21 CFR 111.410(b) | Labels - issuance, use |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |