FDA Inspection 986800 — P. E. Hicks dba Flintstone Herb Company
The FDA completed an inspection of P. E. Hicks dba Flintstone Herb Company on August 26, 2016 in Flintstone, GA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 19 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 26, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Flintstone, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15405 | 21 CFR 111.13(a) | Supervisor - qualified |
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15481 | 21 CFR 111.23(b) | Records - cleaning, pest control |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15583 | 21 CFR 111.155(d)(1) | Components - identify lot received |
| 15599 | 21 CFR 111.160(d)(1) | Labels - identify |
| 15619 | 21 CFR 111.180(b)(1) | Written procedures - packaging, labeling received |
| 15624 | 21 CFR 111.180(b)(3) | Documentation - components |
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 15728 | 21 CFR 111.365(d) | Chemical, microbiological, other test-contaminated components |
| 15733 | 21 CFR 111.365 | Manufacturing operations - prevent contamination |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15810 | 21 CFR 111.570(b)(2) | Record - product complaint; good manufacturing practice |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16068 | 21 CFR 111.35(b)(1)(iii) | Equipment, utensils; maintaining, cleaning, sanitizing |