FDA Inspection 578808 — Packaging Concepts Associates, LLC
The FDA completed an inspection of Packaging Concepts Associates, LLC on May 4, 2009 in Boynton Beach, FL. 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 4, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Boynton Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2022 | 21 CFR 211.188(b)(10) | Documentation of Sampling Performed |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 4375 | 21 CFR 211.188(b)(5) | In-process and laboratory control results |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |