FDA Inspection 1164181 — North American Custom Laboratories, LLC
The FDA completed an inspection of North American Custom Laboratories, LLC on Mar 10, 2022 in Richardson, TX. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 10, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Richardson, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18939 | FDCA 501(a)(2)(A) | Highly potent drugs, prevention of cross-contamination |
| 18954 | FDCA 501(a)(2)(A) | Actionable microbial contamination, adjacent area |
| 18966 | FDCA 501(a)(2)(A) | Non-sterilized and non-depyrogenated, sterile drug |
| 18968 | FDCA 501(a)(2)(A) | Inadequate filter, final product sterilization |
| 18973 | FDCA 501(a)(2)(A) | Disinfecting materials, aseptic processing area |
| 21377 | FDCA 501(a)(2)(A) | Use of non-pharmaceutical grade components |