FDA Inspection 706645 — Pharmaloz Manufacturing Inc.
The FDA completed an inspection of Pharmaloz Manufacturing Inc. on January 20, 2011 in Lebanon, PA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 14 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- January 20, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lebanon, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2019 | 21 CFR 211.188(b)(7) | Documentation of Actual Yield and Theoretical Yield |
| 2203 | 21 CFR 211.186(b)(7) | Theoretical Yield and Percentages |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |