FDA Inspection 1149082 — Hill Dermaceuticals, Inc.
The FDA completed an inspection of Hill Dermaceuticals, Inc. on August 11, 2021 in Sanford, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 11, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sanford, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4320 | 21 CFR 211.84(d)(6) | Microbiological Contamination Exam |