FDA Inspection 920513 — Medical Chemical Corporation
The FDA completed an inspection of Medical Chemical Corporation on Feb 25, 2015 in Torrance, CA. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 25, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Torrance, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 4409 | 21 CFR 211.194(a)(4) | Data secured in course of each test |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |