FDA Inspection 1192551 — Neutraderm, Inc.
The FDA completed an inspection of Neutraderm, Inc. on Dec 9, 2022 in Chatsworth, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 9, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chatsworth, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 3614 | 21 CFR 211.160(b)(4) | Written calibration procedures |