FDA Inspection 708545 — 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 January 5, 2011 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). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 5, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- City Of Industry, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4349 | 21 CFR 211.160(b)(2) | In-process samples representative, identified properly |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |