FDA Inspection 847488 — Grandpa's Compounding Pharmacy, Inc.
The FDA completed an inspection of Grandpa's Compounding Pharmacy, Inc. on September 10, 2013 in Placerville, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 10, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Placerville, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1134 | 21 CFR 211.25(b) | Supervisor Training/Education/Experience |
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4405 | 21 CFR 211.194(a)(2) | Statement of methods and data |