FDA Inspection 1208022 — Parker Laboratories, Inc.
The FDA completed an inspection of Parker Laboratories, Inc. on June 14, 2023 in Fairfield, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 14, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fairfield, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |