FDA Inspection 695503 — Formatech Inc.
The FDA completed an inspection of Formatech Inc. on October 15, 2010 in Andover, MA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 15, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Andover, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1431 | 21 CFR 211.42(c)(10)(ii) | Temperature / Humidity Controls |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4320 | 21 CFR 211.84(d)(6) | Microbiological Contamination Exam |