FDA Inspection 1152160 — BLS Labs LLC
The FDA completed an inspection of BLS Labs LLC on September 3, 2021 in Mesa, AZ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 3, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Mesa, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12257 | 21 CFR 1271.60(c)(2) | Records stating determination not completed |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |
| 12412 | 21 CFR 1271.260(b) | Storage temperatures appropriate |
| 12429 | 21 CFR 1271.265(d) | Shipping conditions appropriate |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |