FDA Inspection 841175 — Pine Pharmacy and Home Care Products Center, Inc.
The FDA completed an inspection of Pine Pharmacy and Home Care Products Center, Inc. on July 19, 2013 in Williamsville, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 19, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Williamsville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 3550 | 21 CFR 211.46(c) | Exhaust systems inadequate to control air contamination |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |