FDA Inspection 1111630 — Transdermal Delivery Solutions Corp. dba Hypospray Pharma
The FDA completed an inspection of Transdermal Delivery Solutions Corp. dba Hypospray Pharma on December 3, 2019 in Palm Beach Gardens, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 3, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Palm Beach Gardens, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |