FDA Inspection 1019019 — Hayward Laboratories, Inc.
The FDA completed an inspection of Hayward Laboratories, Inc. on July 20, 2017 in E Stroudsburg, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 20, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- E Stroudsburg, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4388 | 21 CFR 211.198(a) | Complaints reviewed by Quality Control Unit |