FDA Inspection 825131 — Pallimed Solutions, Inc.
The FDA completed an inspection of Pallimed Solutions, Inc. on March 29, 2013 in Woburn, MA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 29, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Woburn, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1869 | 21 CFR 211.94(c) | Containers & Closures Clean, Sterilized, Pyrogen-free |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |