FDA Inspection 769943 — Bayscience Formulators, LLC
The FDA completed an inspection of Bayscience Formulators, LLC on Feb 29, 2012 in Dudley, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 29, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dudley, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |