FDA Inspection 697186 — H J Harkins Company Inc dba Pharma Pac
The FDA completed an inspection of H J Harkins Company Inc dba Pharma Pac on November 10, 2010 in Grover Beach, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 10, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Grover Beach, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4302 | 21 CFR 211.56(b) | Written sanitation procedures not followed |