FDA Inspection 865905 — Ohlsen Pharmacal Company
The FDA completed an inspection of Ohlsen Pharmacal Company on Feb 10, 2014 in Washington, MO. 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). 18 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 10, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Washington, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15382 | 21 CFR 111.8 | Written procedures - personnel qualifications |
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15447 | 21 CFR 111.15(c)(3) | Cleaning compounds and toxic materials - holding |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15559 | 21 CFR 111.260(k)(1) | Batch record - identifier; labels |
| 15560 | 21 CFR 111.260(k)(2) | Batch record - label |
| 15581 | 21 CFR 111.155(c)(3) | Quality control - components, approve, release |
| 15585 | 21 CFR 111.155(d)(2) | Components - unique identifier |
| 15604 | 21 CFR 111.165(b) | Product received - visually examine invoice, guarantee, cert |
| 15634 | 21 CFR 111.180(b)(3)(ii)(D) | Documentation - required operation; material review, disposi |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15984 | 21 CFR 111.123(a)(8) | Quality control - finished batch, distribution |
| 16046 | 21 CFR 111.503 | Written procedures returned dietary supplement investigation |
| 16066 | 21 CFR 111.35(b)(1)(i) | Written procedures - instruments, controls; calibrating |