FDA Inspection 713642 — American Regent, Inc.
The FDA completed an inspection of American Regent, Inc. on March 15, 2011 in Shirley, 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 15, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Shirley, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3591 | 21 CFR 211.110(b) | In-process materials specifications |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4317 | 21 CFR 211.84(d)(3) | Certificates of Testing (Containers, Closures) |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |
| 4375 | 21 CFR 211.188(b)(5) | In-process and laboratory control results |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |
| 8914 | 21 CFR 314.81(b)(2)(iv)(b) | Mfg and control changes not requiring a supplemental app. |