FDA Inspection 1080372 — Lifetime Value Pharmacy III Inc.
The FDA completed an inspection of Lifetime Value Pharmacy III Inc. on Feb 21, 2019 in Santa Ana, 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). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 21, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Santa Ana, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18936 | FDCA 501(a)(2)(A) | Non-microbial contamination, production area |
| 18941 | FDCA 501(a)(2)(A) | Improper gowning, contamination |
| 18942 | FDCA 501(a)(2)(A) | Personnel habits, contamination |
| 18953 | FDCA 501(a)(2)(A) | Actionable microbial contamination, ISO 5 area |
| 18954 | FDCA 501(a)(2)(A) | Actionable microbial contamination, adjacent area |
| 18955 | FDCA 501(a)(2)(A) | Ceiling tiles, cleanroom |
| 18956 | FDCA 501(a)(2)(A) | Cleanliness, ISO-classified areas |
| 18961 | FDCA 501(a)(2)(A) | Air flow quality, higher classified area |
| 18966 | FDCA 501(a)(2)(A) | Non-sterilized and non-depyrogenated, sterile drug |