FDA Inspection 1165577 — American Cleaning Solutions
The FDA completed an inspection of American Cleaning Solutions on March 28, 2022 in Long Island City, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 18 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 28, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Long Island City, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1876 | 21 CFR 211.180(b) | Record maintenance 1 year (except exempt OTC) |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3615 | 21 CFR 211.160(b)(4) | Test devices not meeting specifications |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |