FDA Inspection 1165719 — Element Materials Technology Oakland-Concord
The FDA completed an inspection of Element Materials Technology Oakland-Concord on March 22, 2022 in Concord, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 22, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Concord, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1223 | 21 CFR 211.67(b)(5) | Cleaning SOPs/equipment protection |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3546 | 21 CFR 211.46(a) | Adequate ventilation not provided |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3555 | 21 CFR 211.48(b) | Drains--Size, Back-siphonage Prevention |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |