FDA Inspection 1043391 — The Micro Connection Enterprises, Inc. DBA Personal Care Performance Group
The FDA completed an inspection of The Micro Connection Enterprises, Inc. DBA Personal Care Performance Group on March 6, 2018 in City Of Industry, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 6, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- City Of Industry, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1927 | 21 CFR 211.166(b) | Accelerated stability studies |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |