FDA Inspection 755886 — Asept Pak Inc.
The FDA completed an inspection of Asept Pak Inc. on December 2, 2011 in Malone, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 2, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Malone, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 4324 | 21 CFR 211.110(b) | In-process materials specifications testing |
| 4359 | 21 CFR 211.170(b)(1) | Retention time of reserve samples, in general |