FDA Inspection 702098 — Glanbia Nutritionals NA, Inc.
The FDA completed an inspection of Glanbia Nutritionals NA, Inc. on December 22, 2010 in West Haven, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 22, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- West Haven, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1371 | 21 CFR 211.101(a) | Batches Formulated to less than 100% |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 4325 | 21 CFR 211.110(a) | Control procedures fail to include the following |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |
| 4376 | 21 CFR 211.188(b)(4) | Weights and measures of components used |
| 4398 | 21 CFR 211.186(b)(6) | Weight or measure at stages of processing |